MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F

Additional Manufacturer Narrative

AS REPORTED, THE BALLOONS OF THE 4 5F MYNXGRIP VASCULAR CLOSURE DEVICES (VCD) POPPED. THE PHYSICIAN INFLATED THE FIRST BALLOON INSIDE THE PATIENT AND THE BALLOON RUPTURED. THE PHYSICIAN INFLATED ¿TWO OR THREE MORE¿ ON THE TABLE AND ALL OF THEM RUPTURED. THERE WAS NO HARM TO THE PATIENT AND A MANUAL HOLD/PRESSURE WAS PERFORMED TO ACHIEVE HEMOSTASIS. THE PHYSICIAN IS A CERTIFIED USER. OTHER ADDITIONAL PATIENT/PROCEDURAL DETAILS WERE REQUESTED BUT WERE UNKNOWN. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT F1816202 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿BALLOON LOSS OF PRESSURE¿ AND ¿BALLOON LOSS OF PRESSURE AT PREP¿ COULD NOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE OF THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED. VESSEL CHARACTERISTICS, ALTHOUGH NOT REPORTED, MAY HAVE CONTRIBUTED TO THE EVENT THAT OCCURRED IN THE PATIENT. HANDLING FACTORS, SUCH AS EXCESSIVE INFLATION FORCE, MAY HAVE CONTRIBUTED TO THE EVENTS THAT OCCURRED DURING PREP. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), WHICH IS NOT INTENDED AS A MITIGATION OF RISK, USERS ARE INSTRUCTED TO DISCARD THE DEVICE IF THE BALLOON DOES NOT MAINTAIN PRESSURE. NEITHER THE PHR REVIEW, NOR THE INFORMATION AVAILABLE SUGGESTS THAT THE EVENT EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

Additional Manufacturer Narrative

THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

Description of Event or Problem

AS REPORTED, THE BALLOONS OF THE 4 5F MYNX GRIP VASCULAR CLOSURE DEVICES (VCD) POPPED. THE PHYSICIAN INFLATED THE FIRST BALLOON INSIDE THE PATIENT AND THE BALLOON RUPTURED. THE PHYSICIAN INFLATED ¿TWO OR THREE MORE¿ ON THE TABLE AND ALL OF THEM RUPTURED. THERE WAS NO HARM TO THE PATIENT AND A MANUAL HOLD/PRESSURE WAS PERFORMED TO ACHIEVE HEMOSTASIS. THE PHYSICIAN IS A CERTIFIED USER. OTHER ADDITIONAL PATIENT/PROCEDURAL DETAILS WERE REQUESTED BUT WERE UNKNOWN. THE COMPLAINT PRODUCTS WILL NOT BE RETURNED AS IT HAS BEEN DISCARDED HOWEVER, THE SIX (6) UNUSED MYNX DEVICES FROM THE SAME LOT NUMBER WILL BE RETURNED.