RIGIFLEX II

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II DILATATION BALLOON WAS USED IN THE LOWER ESOPHAGUS AND CARDIA DURING A DILATION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON SUDDENLY BURST WHEN ATTEMPTED TO BE INFLATED. THE PROCEDURE WAS NOT COMPLETED AS THE SAME DEVICE WAS UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY.

Additional Manufacturer Narrative

BLOCK H6: PROBLEM CODE 1074 CAPTURES THE REPORTABLE ISSUE OF BALLOON BURST. BLOCK H10: INVESTIGATION RESULT A VISUAL EXAMINATION OF THE RETURNED COMPLAINT DEVICE FOUND THAT THE PRODUCT WAS RECEIVED INSIDE A PLASTIC POUCH WHICH CONTAINED YELLOW CONTAMINATION SPOTS; THEREFORE THE DEVICE WAS NOT OPENED NOR WAS THE BALLOON REMOVED FROM THE BAG. THE DEVICE WAS MANIPULATED FROM THE OUTSIDE, AND IT WAS OBSERVED THAT THE BALLOON HAD AN OPENING FROM THE DISTAL END TO THE PROXIMAL END OF THE BALLOON MATERIAL WHICH CONFIRMED THE REPORTED EVENT OF BALLOON BURST. THIS FAILURE IS LIKELY DUE TO FACTORS OR CONDITIONS RELATED TO PROCEDURE DURING THE USE OF THE DEVICE, SUCH AS THE MANNER IN WHICH THE DEVICE WAS HANDLED AND MANIPULATED, THAT COULD HAVE AFFECTED ITS PERFORMANCE AND ITS INTENDED PURPOSE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU)/PRODUCT LABEL.

Additional Manufacturer Narrative

(B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II DILATATION BALLOON WAS USED IN THE LOWER ESOPHAGUS AND CARDIA DURING A DILATION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON SUDDENLY BURST WHEN ATTEMPTED TO BE INFLATED. THE PROCEDURE WAS NOT COMPLETED AS THE SAME DEVICE WAS UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY.