VIDA BALLOON VALVULOPLASTY CATHETER

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY WOULD NOT HOLD PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

H10: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT INVESTIGATION SUMMARY: ONE VIDA PTV DILATATION CATHETER HAS BEEN RECEIVED FOR THE EVALUATION. ON THE VISUAL EVALUATION, THE DEVICE WAS NOTED BLOODY AND NO OTHER SPECIFIC ANOMALIES WERE NOTED. ON THE FUNCTIONAL EVALUATION, AN IN-HOUSE PRESTO INFLATION DEVICE WAS USED TO INFLATE THE BALLOON TO 6 ATM. BALLOON INFLATED AND MAINTAINED PRESSURE AND THE BALLOON WAS THEN DEFLATED WITHOUT ISSUE. NO OTHER FUNCTIONAL TESTING WAS PERFORMED. THEREFORE THE INVESTIGATION FOR THE REPORTED INFLATION ISSUE WAS UNCONFIRMED, AS THE BALLOON WAS SUCCESSFULLY INFLATED WITHOUT ANY ISSUE UPON INFLATION. A DEFINITIVE ROOT CAUSE FOR THE REPORTED INFLATION ISSUE COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G., PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. H10: D4 (EXPIRY DATE: 07/2022), G3. H11: E1, G2, H6 (METHOD, RESULT, CONCLUSION). H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : SEE H10.

Additional Manufacturer Narrative

AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 07/2022).

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY WOULD NOT HOLD PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.