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

Model Number	4648
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.
Event or Problem Description
Boston scientific received information that this whisper wire broke off and retained in coronary sinus.The product was used as is.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.Supplemental correction report is being filed as parent record (b)(4) is a duplicate to tw record (b)(4).
Event or Problem Description
Boston scientific received information that this whisper wire broke off and retained in coronary sinus.The product was used as is.No additional adverse patient effects were reported.

• 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: 8581330
• Report Number: 2124215-2019-08556
• Device Sequence Number: 3030129
• Product Code: DQX
• UDI-Device Identifier: 20802526512982
• UDI-Public: 20802526512982
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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: 01/20/2021
• Device Model Number: 4648
• Device Catalogue Number: 4648
• Device Lot Number: 23220691
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 08/28/2019
• 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