MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY PRO; CATHETER, PERCUTANEOUS

Model Number	8101
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an implant procedure on (b)(6) 2019 a guiding catheter was attempted to be used to insert the left ventricle lead but the part around the tip got lifted at the bifurcation.It was determined due to safety precautions to discontinue use.The left ventricle lead was inserted successfully without the use of a catheter.No adverse health outcomes were reported.This catheter will not be returned as indicated during the initial report.
Additional Manufacturer Narrative
This catheter is not expected for return.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that on (b)(6)2019 during an implant procedure a child catheter was attempted to be used to assist in inserting the left ventricle lead.It was indicated that the part around the tip of the catheter lifted at the bifurcation part, so the usage was discontinued for safety precaution.The left ventricle lead was successfully placed without using a catheter.No adverse health effects were reported.This catheter is not expected for return.

• Brand Name: ACUITY PRO
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8558226
• Report Number: 2124215-2019-07689
• Device Sequence Number: 2308506
• Product Code: DQY
• UDI-Device Identifier: 08714729932468
• UDI-Public: 08714729932468
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132914
• 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,Followup
• Report Date (Section B): 05/09/2019

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: 08/15/2020
• Device Model Number: 8101
• Device Catalogue Number: 8101
• Device Lot Number: 22521619
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 05/09/2019
• Patient Sequence Number: 1