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 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of an imager diagnostic catheter in the un-opened sterile pouch.Tensile strength inspection of the returned product was performed and the device failed to meet specification for tip detachment.The device tip was manually straightened and the tip detached.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

An unused 5f bern imager ii angiographic catheter in it's unopened original packaging was returned to boston scientific from a customer associated with mdr id 2134265-2019-13161.There was no reported complaint against this returned device.The device was intact upon receipt.Boston scientific carried out a tensile strength test on the returned device resulting in a tip detachment concluding that the device failed to meet specification.This event is associated with previously reported field action (b)(4) 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: 10474616
• MDR Text Key: 207920656
• Report Number: 2134265-2020-11776
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729354871
• UDI-Public: 08714729354871
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K121694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2020
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000134600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2018
• 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