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

Model Number	4648
Medical Device Problem Codes	Difficult to Insert (1316); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that multiple guidewires had been used during a difficult implant procedure.When the physician used the final wire, it was observed that approximately 3 centimeters of a different guidewire had broken off and was abandoned within the sinus coronary branch.The patient was stable with no additional consequences.

• 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: 8818687
• Report Number: 2124215-2019-14459
• Device Sequence Number: 3027143
• Product Code: DQX
• UDI-Device Identifier: 00802526512988
• UDI-Public: 00802526512988
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 07/23/2019

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: 01/24/2021
• Device Model Number: 4648
• Device Catalogue Number: 4648
• Device Lot Number: 23247511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1