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

Model Number	8103
Medical Device Problem Codes	Failure to Cut (2587); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this guide catheter was used to access the coronary sinus during a cardiac resynchronization therapy pacemaker (crt-p) implant procedure, but it was broken during slitting.This caused great difficulty for doctor to cut the final part, which remained on the left ventricular (lv) lead.Doctor commented that this behavior should not occur to this kind of catheters, as it implies risk of damaging the lead and dislodging it.Delivery system was discarded at hospital facilities.This catheter is not expected to be returned.No adverse patient effects were reported.

• 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: 12271446
• Report Number: 2124215-2021-22778
• Device Sequence Number: 19909447
• Product Code: DQY
• UDI-Device Identifier: 08714729932543
• UDI-Public: 08714729932543
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K132914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2021

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: 03/25/2022
• Device Model Number: 8103
• Device Catalogue Number: 8103
• Device Lot Number: 25403914
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 08/03/2021
• Patient Sequence Number: 1