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

Model Number	7518
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/03/2020
Type of Reportable Event	Malfunction
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.The balloon was loosely folded.The exit notch was damaged.The shaft was stretched down starting 18.5cm from the exit notch.The inner shaft was separated starting 18.5cm from the exit notch.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed that there was damage consistent with difficulty removing a mandrel or guidewire.
Event or Problem Description
Reportable based on device analysis completed on 12jun2020.It was reported that stylet removal difficulties were encountered.During unpacking of a 2.00mm x 12mm apex balloon catheter, it was noted that the tip of the stylet was damaged and there was difficulty in removing it.A new balloon was used and the procedure was completed.No patient serious injury or adverse event were reported and the patient's status was stable.No patient complications nor injuries were reported.However, returned device analysis revealed shaft separation.

• 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: 10224750
• Report Number: 2134265-2020-08353
• Device Sequence Number: 18961533
• Product Code: LOX
• UDI-Device Identifier: 08714729475477
• UDI-Public: 08714729475477
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/02/2020

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: 01/21/2023
• Device Model Number: 7518
• Device Catalogue Number: 7518
• Device Lot Number: 0025081202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 07/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1