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

Model Number	38270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10474604
• Report Number: 2134265-2020-11774
• Device Sequence Number: 2939594
• Product Code: DQO
• UDI-Device Identifier: 08714729354888
• UDI-Public: 08714729354888
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/31/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2020
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000134011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 92484513-FA
• Patient Sequence Number: 1