MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY WHISPER VIEW; WIRE, GUIDE, CATHETER

Model Number	4647
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
Event or Problem Description
It was reported that during the lead implant procedure the tip of the guidewire broke off when retracted.Physician was not able to remove the foreign body.No adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
Additional Manufacturer Narrative
This lead was returned to boston scientific's post market quality assurance laboratory and visual inspection confirmed the guidewire tip was broke.The product appeared severely manipulated as the distal tip and body were kinked and the polymer tip had a detached section.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
Event or Problem Description
It was reported that during the lead implant procedure the tip of the guidewire broke off when retracted.Physician was not able to remove the foreign body.No adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

• Brand Name: ACUITY WHISPER VIEW
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9125585
• Report Number: 2124215-2019-19704
• Device Sequence Number: 11377420
• Product Code: DQX
• UDI-Device Identifier: 20802526512937
• UDI-Public: 20802526512937
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2021
• Device Model Number: 4647
• Device Catalogue Number: 4647
• Device Lot Number: 23399580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention