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

Model Number 38265

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

Device eval by manufacturer: returned product consisted of an imager diagnostic catheter in the original pouch.The tip was separated from the shaft.

Event Description

It was reported that the catheter tip broke.The imager ii angiographic catheter was removed from the packaging for review.Upon touching the tip, the tip broke.The device was not used.

• 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): TELEFLEX MEDICAL; unit 7 8 and 9; annacotty li ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9520263
• MDR Text Key: 177131228
• Report Number: 2134265-2019-16175
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729355892
• UDI-Public: 08714729355892
• Combination Product (y/n): N
• PMA/PMN Number: K120893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/25/2020
• Device Model Number: 38265
• Device Catalogue Number: 38265
• Device Lot Number: 0000134946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Date Manufacturer Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2018
• 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