MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMAGER II ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 38270

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

Patient Problem No Patient Involvement (2645)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of an imager diagnostic catheter in the un-opened sterile pouch.Visual examination revealed that a kink was present located 26cm from the strain relief.The device was functionally tested with a test guidewire.The guidewire was inserted into the lumen from the hub end of the device and the guidewire transcended through the lumen until it reached approximately 2.5cm from the tip and the tip separated from the shaft.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

Event Description

An unused 5f contra imager ii angiographic catheter in it's unopened original packaging was returned to boston scientific from a customer.There was no reported complaint against this returned device.The device was intact upon receipt.Boston scientific carried out functional testing on the returned device which resulted in a tip detachment.This event is associated with previously reported field action 92484513-fa with product being removed from the field.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): TFX ENGINEERING LIMITED T/A; unit 7 8 and 9; annacotty, li ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10475944
• MDR Text Key: 205090030
• Report Number: 2134265-2020-11766
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729355403
• UDI-Public: 08714729355403
• Combination Product (y/n): N
• PMA/PMN Number: K121694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/01/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2020
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000134631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 92484513-FA
• Patient Sequence Number: 1