RUSCH BRONCHOPART DOUBLE LUMEN LEFT

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT. CHANGE NEW TUBE." NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

(B)(4). ONE (1) ACTUAL SAMPLE RECEIVED FOR INVESTIGATION. THE LOT NUMBER PRINTED ON THE PACKAGING COULD NOT BE VERIFIED AS THE PACKAGING WAS NOT RETURNED. THE INFORMATION IN SAP MENTION THAT THE LEAKAGE WAS FOUND DURING PRE -TEST, HOWEVER INITIAL VISUAL INSPECTION OF THE SAMPLE RECEIVED INDICATED EVIDENCE OF PRIOR CLINICAL USE, AS TRACE SEDIMENT WAS OBSERVED ON THE CLEAR CUFF. FOLLOWING FUNCTIONAL TESTING, VISUAL INSPECTION USING KEYENCE DIGITAL MICROSCOPE, A TEAR/SPLIT WAS IDENTIFIED ON THE CLEAR CUFF SURFACE. THE DEFECT PRESENTS AS AN IRREGULAR OPENING WITH JAGGED EDGES, INDICATIVE OF MATERIAL RUPTURE. BASED ON THE MORPHOLOGY AND LOCATION OF THE DEFECT, THE DAMAGE MAY HAVE BEEN INDUCED OR EXACERBATED BY INTERACTION WITH PATIENT ANATOMICAL STRUCTURES (E.G., CONTACT WITH TEETH) DURING CLINICAL USE. MECHANICAL STRESS, FRICTION, OR LOCALIZED PRESSURE ASSOCIATED WITH INSERTION, POSITIONING, OR IN-USE CONDITIONS MAY HAVE CONTRIBUTED TO MATERIAL FATIGUE AND SUBSEQUENT RUPTURE AT A SUSCEPTIBLE AREA OF THE CUFF. THEREFORE, COMPLAINT ON CUFF LEAKAGE WAS CONFIRMED. FUNCTIONAL TESTING WAS PERFORMED USING A WATER LEAK TEST IN ACCORDANCE WITH SPM TO VERIFY THE PRESENCE OF LEAKAGE. BOTH THE CLEAR AND BLUE CUFFS WERE INFLATED TO 70 MBAR (APPROXIMATELY 71.4 CM H2O) USING A CALIBRATED CUFF PRESSURE GAUGE. DURING THE TEST, THE BLUE CUFF MAINTAINED INFLATED, WHEREAS THE CLEAR CUFF WAS OBSERVED TO DEFLATE, INDICATING A LOSS OF INTEGRITY. UPON IMMERSION IN A WATER BATH, AIR BUBBLES EMERGED FROM THE CLEAR CUFF, CONFIRMING THE PRESENCE OF LEAKAGE. THE DEVICE HISTORY RECORD FOR LOT 40E25B4242 WAS REVIEWED AND NO ISSUE RELATED TO COMPLAINT WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. BASED ON IFU, VARIOUS BONY ANATOMICAL STRUCTURES (E.G. TEETH) WITHIN THE INTUBATION ROUTES OR ANY INTUBATION AID WITH SHARP SURFACES CAN DAMAGE THE INTEGRITY OF THE CUFF. CARE MUST BE TAKEN TO AVOID DAMAGING THE THIN-WALLED CUFF DURING INTUBATION, WHICH COULD RESULT IN THE PATIENT REQUIRING THE TRAUMA OF EXTUBATION AND RE-INTUBATION. IF THE CUFF IS DAMAGED, THE TUBE SHOULD NOT BE USED. WATER LEAK TEST WAS PERFORMED AS PER SPM AND OBSERVE FOR LEAKAGE OR AIR BUBBLES ESCAPING OUT WHICH INDICATE LEAK WAS OBSERVED. VISUAL INSPECTION OF THE RETURNED COMPLAINT SAMPLE IDENTIFIED A TEAR/SPLIT ON THE CLEAR CUFF OF THE BRONCHIAL TUBE, CONSISTENT WITH THE REPORTED LEAKAGE. THE DEFECT PRESENTS AS AN IRREGULAR OPENING WITH JAGGED EDGES, INDICATIVE OF MATERIAL RUPTURE. ALTHOUGH SAP RECORDS INDICATE THAT LEAKAGE WAS IDENTIFIED DURING PRE-TESTING, THE INITIAL VISUAL INSPECTION OF THE RECEIVED SAMPLE SHOWED EVIDENCE OF PRIOR CLI NICAL USE, AS TRACE SEDIMENT WAS OBSERVED ON THE CUFF SURFACE. THIS SUGGESTS THAT THE DAMAGE WAS LIKELY INTRODUCED DURING CLINICAL APPLICATION, POTENTIALLY DUE TO INTERACTION WITH PATIENT ANATOMICAL STRUCTURES (E.G., CONTACT WITH TEETH). BASED ON THE INVESTIGATION CONDUCTED, LEAKAGE WAS IDENTIFIED AT THE CLEAR CUFF, AS EVIDENCED BY THE EMERGENCE OF AIR BUBBLES DURING THE WATER LEAK TEST. VISUAL INSPECTION OF THE AFFECTED AREA REVEALED A TEAR/SPLIT ON THE SURFACE OF THE CLEAR CUFF. THE DEFECT PRESENTS AS AN IRREGULAR OPENING WITH JAGGED EDGES. ALTHOUGH SAP RECORDS INDICATE THAT LEAKAGE WAS IDENTIFIED DURING PRE-TESTING, THE INITIAL VISUAL INSPECTION OF THE RECEIVED SAMPLE SHOWED EVIDENCE OF PRIOR CLINICAL USE, AS TRACE SEDIMENT WAS OBSERVED ON THE CUFF SURFACE. THIS SUGGESTS THAT THE DAMAGE WAS LIKELY INTRODUCED DURING CLINICAL APPLICATION, POTENTIALLY DUE TO INTERACTION WITH PATIENT ANATOMICAL STRUCTURES (E.G., CONTACT WITH TEETH). TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

Description of Event or Problem

IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT. CHANGE NEW TUBE." NO PATIENT INVOLVEMENT.