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

Model Number	7514
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an apex push balloon catheter in two pieces.The balloon was loosely folded with blood in the lumen and balloon.The outer shaft, inner shaft, balloon and tip were microscopically examined.The shaft was completely stretched and separated 124.3cm from the hub.24mm of the outer shaft is torn starting 2.1cm from the distal tip.The fractured/separated end of the shaft was stretched and jagged which indicates the shaft separation was due to tensile forces.There are numerous hypotube and shaft kinks.The tip is damaged.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on the device analysis completed on 19sep2019.This device was received with no reported issues.However, returned device analysis revealed shaft separation.

• Brand Name: APEX PUSH
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9180187
• Report Number: 2134265-2019-12134
• Device Sequence Number: 14095386
• Product Code: LOX
• UDI-Device Identifier: 08714729476016
• UDI-Public: 08714729476016
• 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
• Report Date (Section B): 10/10/2019

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: 05/19/2022
• Device Model Number: 7514
• Device Catalogue Number: 7514
• Device Lot Number: 0023817363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1