ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT

Additional Manufacturer Narrative

DEVICE COMMON NAME: QIJ. PMA/510(K) # DEN180062. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

Description of Event or Problem

16-03 ¿ PATIENT # (B)(6): HEMORRHAGE. ON (B)(6) 2021 THE PATIENT UNDERWENT ENDOSCOPIC ULTRASOUND-GUIDED PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENTS USING THE ECHOTIP INSIGHT MEASUREMENT SYSTEM. CONSCIOUS SEDATION/MAC WAS PROVIDED WITH PROPOFOL AND KETAMINE. SEVERE PORTAL HYPERTENSIVE GASTROPATHY WAS PRESENT. ESOPHAGEAL VARICES WERE PRESENT (EXTENDING ALONG LESSER CURVATURE), WITH THE LARGEST VARIX MEASURING 5MM. THE LEFT PORTAL VEIN WAS ACCESSED TRANSGASTRIC. THE PUNCTURE LOCATION WAS INTRAHEPATIC; 2.5 MM OF LIVER PARENCHYMA WAS PUNCTURED THROUGH. THE DIAMETER OF THE TARGET SEGMENT OF THE LEFT PORTAL VEIN WAS 4 MM. THE AVERAGE PORTAL VEIN (PRESSURE) MEASUREMENT WAS 35 (MMHG). THE LEFT HEPATIC VEIN WAS ACCESSED TRANSGASTRIC. THE PUNCTURE LOCATION WAS INTRAHEPATIC; 1.7 MM OF LIVER PARENCHYMA WAS PUNCTURED THROUGH. THE DIAMETER OF THE TARGET SEGMENT OF THE LEFT HEPATIC VEIN WAS 3 MM. THE AVERAGE HEPATIC VEIN (PRESSURE) MEASUREMENT WAS 21.7 (MMHG). THE ECHOTIP INSIGHT PORTAL PRESSURE GRADIENT MEASUREMENT WAS 13 (MMHG). NO ADDITIONAL PROCEDURES WERE PERFORMED. POST-PROCEDURE HEMORRHAGE WAS IDENTIFIED ON THE DAY OF THE PROCEDURE. THE SITE NOTED THE FOLLOWING, ¿BLEEDING FROM PUNCTURE SITE, SECOND OGD AND CLIPPING PERFORMED. PATIENT WAS SUFFERED FROM HEPATIC ENCEPHALOPATHY AND NOW IN INTENSIVE CARE.¿ THE TREATMENT INCLUDED OGD (OESOPHAGO-GASTRO-DUODENOSCOPY) WITH CLIPPING. THE SITE HAS BEEN QUERIED TO CONFIRM/CLARIFY PUNCTURE SITE (GASTRIC). THE INVESTIGATOR INDICATED THAT THE EVENT WAS RELATED TO THE ECHOTIP INSIGHT DEVICE BUT WAS NOT RELATED TO THE PORTAL PRESSURE GRADIENT MEASUREMENT PROCEDURE USING THE ECHOTIP INSIGHT. THE INVESTIGATOR NOTED THE FOLLOWING, ¿BLEEDING FROM PUNCTURE SITE.¿ THE INVESTIGATOR ALSO NOTED THAT THE EVENT WAS ALSO RELATED TO A PRE-EXISTING CONDITION, ¿PORTAL HYPERTENSION.¿ INVESTIGATOR MUST USE THE FOLLOWING GUIDELINES TO REPORT RELATIONSHIP TO STUDY DEVICE AND/OR PROCEDURE: NOT RELATED: WHEN THE EVENT IS CLEARLY DUE TO ANOTHER CAUSE OR WHEN A CAUSAL RELATIONSHIP IS NOT CONSIDERED REASONABLY POSSIBLE. RELATED: WHEN THE DEVICE/PROCEDURE IS CONSIDERED TO BE CAUSAL OR CONTRIBUTORY TO THE EVENT OR WHEN A CAUSAL RELATIONSHIP IS CONSIDERED REASONABLY POSSIBLE THE EVENT WAS CONSIDERED SERIOUS BY THE INVESTIGATOR AND THE ECHOTIP INSIGHT MEASUREMENT SYSTEM WAS NOT CONSIDERED DEFICIENT. THE USER INDICATED THAT THEY WERE SATISFIED WITH THE QUALITY AND PERFORMANCE OF THE ECHOTIP MEASUREMENT SYSTEM. PATIENT IN ICU, REMAINS IN STUDY.

Description of Event or Problem

SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS ON THE (B)(6) 2022.

Additional Manufacturer Narrative

DEVICE COMMON NAME: QIJ. PMA/510(K) # DEN180062. DEVICE EVALUATION: 1 ECHO PPG DEVICE OF LOT NUMBER C1774163 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: N/A. DOCUMENT REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION, ALL ECHO-PPG DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO PPG OF LOT NUMBER C1774163 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1774163. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0123-2, WHICH INFORMS THE USER ABOUT THE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH GI ENDOSCOPY INCLUDE, BUT ARE NOT LIMITED TO: ALLERGIC REACTION MEDICATION, ALLERGIC REACTION TO NICKEL, ASPIRATION, BURN, CARDIAC ARRHYTHMIA OR ARREST , FEVER , HAEMORRHAGE , HYPOTENSION, INFECTION , PAIN/DISCOMFORT , PERFORATION , RESPIRATORY DEPRESSION OR ARREST AND SEPSIS. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: N/A. ROOT CAUSE REVIEW: A POSSIBLE ROOT CAUSE OF THE HAEMORRHAGE COULD BE ATTRIBUTED TO PRE EXISTING CONDITION. IE PORTAL HYPERTENSION. THE PRESSURE GRADIENT MEASUREMENT WAS 35-21.7=13.3 MMHG WHICH BECOMES 'SEVERE' WHEN >12 MMHG (DECOMPENSATED STAGE)* WITH THE RISK OF RUPTURE OF VARICES AND MIGHT HAVE CONTRIBUTED TO THIS BLEEDING. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

Description of Event or Problem

SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE UPDATES MADE TO THE IMDRF CODING ON 01-AUG-2023: G CODE UPDATED FROM 'G04092 - NEEDLE' TO 'G07001 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE'.

Additional Manufacturer Narrative

PRODUCT CODE: QIJ PMA 510K #DEN180062. DEVICE EVALUATION 1 ECHO PPG DEVICE OF LOT NUMBER C1774163 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW INCLUDING IFU REVIEW PRIOR TO DISTRIBUTION, ALL ECHO-PPG DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO PPG OF LOT NUMBER C1774163 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1774163. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0123-2, WHICH INFORMS THE USER ABOUT THE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH GI ENDOSCOPY INCLUDE, BUT ARE NOT LIMITED TO: ALLERGIC REACTION MEDICATION, ALLERGIC REACTION TO NICKEL, ASPIRATION, BURN, CARDIAC ARRHYTHMIA OR ARREST , FEVER , HAEMORRHAGE , HYPOTENSION, INFECTION , PAIN/DISCOMFORT , PERFORATION , RESPIRATORY DEPRESSION OR ARREST AND SEPSIS. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE ROOT CAUSE REVIEW A POSSIBLE ROOT CAUSE OF THE HAEMORRHAGE COULD BE ATTRIBUTED TO PRE EXISTING CONDITION.IE PORTAL HYPERTENSION. THE PRESSURE GRADIENT MEASUREMENT WAS 35-21.7=13.3 MMHG WHICH BECOMES 'SEVERE' WHEN >12 MMHG (DECOMPENSATED STAGE)* WITH THE RISK OF RUPTURE OF VARICES AND MIGHT HAVE CONTRIBUTED TO THIS BLEEDING. SUMMARY COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.