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

Model Number 38270

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2018 based on aware date and occurrences of previous referenced events.Device evaluated by manufacturer: returned product to boston scientific consisted of an imager diagnostic catheter in the sterile pouch.It was reported that the device tip was broken intentionally by the customer.The device was examined for damage, or any irregularities.The device showed multiple areas of bends/kinks.The kinks that were noticed on the device were due to the shipment of the device in the folded manner.It was noticed inside of the sterile pouch that the tip was separated from the shaft.Inspection of the remainder of the device, apart from the observed damage revealed no damage, or irregularities.The complaint stated that the physician broke the tip to prove the fragility of the tip, however, it is not possible to determine how much force the physician used to break the tip, and no way of determining how that would compare to the device design force specification.

Event Description

The hospital previously experienced tip detachments with three 5fr imager ii angiographic catheters captured within manufacturer report #s (b)(4).The physician and his team took this 5fr imager ii angiographic catheter of the same batch, and purposely broke the tip of the catheter to prove the fragility of the device.The catheter was not used on a patient.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
• MDR Report Key: 10577655
• MDR Text Key: 208774558
• Report Number: 2134265-2020-13241
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729355496
• UDI-Public: 08714729355496
• 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,foreig
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000118462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: 92484513-FA
• Patient Sequence Number: 1