MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION APEX FLEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	7522
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the circumflex artery.A 1.50mm x 15mm apex flex balloon catheter was advanced for dilatation.However, upon inflation, it was noted that the shaft separated about 1 foot from the distal end of the balloon tip.The device was retrieved and the procedure was completed after stenting.There was a delay in the procedure for more than half an hour but no patient complications were reported and patient was fine.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the circumflex artery.A 1.50mm x 15mm apex flex balloon catheter was advanced for dilatation.However, upon inflation, it was noted that the shaft separated about 1 foot from the distal end of the balloon tip.The device was retrieved and the procedure was completed after stenting.There was a delay in the procedure for more than half an hour but no patient complications were reported and patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an apex balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at the midshaft bond.There was contrast and blood in the inflation lumen, contrast in the balloon, and blood in the guidewire lumen.The balloon was loosely folded.The device was soaked in a water bath for two days to loosen the blood and contrast in the device.Operations engineering was called down to review the device and it was determined that further investigation into the separation would be necessary.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: APEX FLEX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9196197
• Report Number: 2134265-2019-12366
• Device Sequence Number: 447475
• Product Code: LOX
• UDI-Device Identifier: 08714729475583
• UDI-Public: 08714729475583
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7522
• Device Catalogue Number: 7522
• Device Lot Number: 0023720912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1