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.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based on device analysis completed on 23jul2020.A 5f bern imager ii angiographic catheter was returned to bsc from a customer with no reported complaint against the device.Device analysis on the returned device found that the device failed tensile testing leading to a tip detachment.

• 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: 10417812
• MDR Text Key: 203300208
• Report Number: 2134265-2020-10972
• 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: 08/17/2020

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: 09/12/2020
• 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
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/17/2020
• 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