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

Model Number	H7493895912200
Medical Device Problem Codes	Hole In Material (1293); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that balloon pinhole occurred.A 2.00 mm x 12 mm apex¿ balloon catheter was selected for use to dilate a lesion.However, when the balloon was flushed and prepped, it was felt that the balloon material was compromised and a pinhole was noted.The device was not used inside the patient and the procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Returned product consisted of a apex balloon catheter.The balloon was loosely folded with contrast in the balloon and lumen.There were numerous hypotube kinks.There was tip damage.Functional testing with an inflation filled with water was used to inflate the balloon to the rated burst pressure and revealed no damages.Inspection of the proximal and distal markerband did not reveal any damages.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
Event or Problem Description
It was reported that balloon pinhole occurred.A 2.00mm x 12mm apex balloon catheter was selected for use to dilate a lesion.However, when the balloon was flushed and prepped, it was felt that the balloon material was compromised and a pinhole was noted.The device was not used inside the patient and the procedure was completed with a different device.No patient complications were reported.

• 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: 6511278
• Report Number: 2134265-2017-03854
• Device Sequence Number: 18998373
• Product Code: LOX
• UDI-Device Identifier: 08714729475477
• UDI-Public: (01)08714729475477(17)20200131(10)20203773
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/01/2017

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 Expiration Date: 01/31/2020
• Device Model Number: H7493895912200
• Device Catalogue Number: 38959-1220
• Device Lot Number: 20203773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2017
• Supplement Report FDA Received Date: 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1