MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE APEX¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7493895940200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	11/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that balloon rupture and vessel perforation occurred.The target lesion was located in the posterior descending artery (pda).A 2.00mm x 40mm apex¿ balloon catheter was advanced for dilatation.However, during the first inflation at 12 atmospheres, the balloon ruptured.A perforation on the artery was then noted and a stent was deployed to cover the perforation.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: returned device consisted of a apex balloon catheter.The balloon was loosely folded, with blood and in the wire lumen, hub and balloon.The tip, balloon, hypotube and distal shaft were microscopically and tactile inspected.Inspection revealed a small pinhole in the balloon material at the distal edge of the distal markerband with numerous kinks in the hypotube.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
It was reported that balloon rupture and vessel perforation occurred.The target lesion was located in the posterior descending artery (pda).A 2.00mm x 40mm apex¿ balloon catheter was advanced for dilatation.However, during the first inflation at 12 atmospheres, the balloon ruptured.A perforation on the artery was then noted and a stent was deployed to cover the perforation.No patient complications were reported and the patient's status was fine.

• Brand Name: APEX¿
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6185163
• Report Number: 2134265-2016-11804
• Device Sequence Number: 1069844
• Product Code: LOX
• UDI-Device Identifier: 08714729475910
• UDI-Public: (01)08714729475910(17)20190930(10)19776998
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: H7493895940200
• Device Catalogue Number: 38959-4020
• Device Lot Number: 19776998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 01/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention