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

Model Number	4643
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the implant procedure, the physician experienced difficulty removing the guidewire through the lead.The original lead was able to be implanted and no patient consequences 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: 8524030
• Report Number: 2124215-2019-06470
• Device Sequence Number: 1884259
• Product Code: DQX
• UDI-Device Identifier: 00802526512889
• UDI-Public: 00802526512889
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K110479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2019

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: 08/23/2020
• Device Model Number: 4643
• Device Catalogue Number: 4643
• Device Lot Number: 22562988
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1