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

Model Number	7528
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an apex balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks to the hypotube, inflation lumen, and guide wire lumen.Microscopic examination revealed that the guide wire lumen prolapsed and has a hole in it at approximately 67.5mm from the tip.There is a puncture mark to the inflation lumen approximately 69mm from the tip.There is blood in the guide wire lumen and the balloon is partially loosely folded.No other damage or irregularities.Product analysis found damage to the guide wire lumen that would prevent a guide wire from passing thru.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2019.It was reported that loading difficulties were encountered.A 2.00mm x 40mm apex balloon catheter was selected for use to dilate the lesion.However, it was noted that the device was unable to be loaded onto the wire.The procedure was completed with a different device.No patient complications were reported.However, returned device analysis revealed prolapse and hole in guidewire lumen and puncture mark in the inflation lumen.

• Brand Name: APEX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8569982
• Report Number: 2134265-2019-04470
• Device Sequence Number: 1836133
• Product Code: LOX
• UDI-Device Identifier: 08714729475910
• UDI-Public: 08714729475910
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 05/01/2019

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 Expiration Date: 11/19/2021
• Device Model Number: 7528
• Device Catalogue Number: 7528
• Device Lot Number: 0022964317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1