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

Model Number 7514

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2019

Event Type  malfunction  

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 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
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9180187
• MDR Text Key: 163154173
• Report Number: 2134265-2019-12134
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729476016
• UDI-Public: 08714729476016
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1