TRIPLE-LOOP SNARE RETRIEVAL KIT

Description of Event or Problem

REPORTER STATED "THE RADIOPAQUE BAND FROM THE DETACHMENT REMOVAL KIT WAS INSIDE THE PATIENT." THE BAND WAS RETRIEVED.

Additional Manufacturer Narrative

THE SAMPLE IS NOT AVAILABLE FOR RETURN. THE INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.

Additional Manufacturer Narrative

WE CONDUCTED A THOROUGH REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS FOR THIS LOT AND FOUND NO DEVIATIONS OR NON-CONFORMANCES. NO SAMPLES WERE RETURNED BY THE CUSTOMER FOR EVALUATION. ADDITIONALLY, THE PHOTOGRAPHIC AND VIDEOGRAPHIC EVIDENCE PROVIDED BY THE CUSTOMER APPEARED TO SUPPORT THE REPORTED ALLEGATION. THE RADIOPAQUE BAND DETACHING FROM THE RETRIEVAL KIT MAY HAVE RESULTED FROM A VARIETY OF POTENTIAL FACTORS LIKE EXCESSIVE MECHANICAL FORCE OR INSUFFICIENT BONDING. HOWEVER, WITHOUT RECEIVING THE SAMPLE, WE ARE UNABLE TO CONDUCT A COMPREHENSIVE INVESTIGATION. AS A RESULT, WE ARE UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE OR IDENTIFY AN APPROPRIATE CORRECTIVE ACTION AT THIS TIME. THE DESIGN TEAM HAS BEEN NOTIFIED TO ENSURE THEY ARE AWARE OF THE ISSUE AND CAN EVALUATE POTENTIAL IMPROVEMENTS TO PREVENT RECURRENCE. ADDITIONAL INFORMATION PROVIDED IN H.6. AND H.11.