MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	7580
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.Vascular access was obtained via the femoral artery.The target lesion was located in the distal left circumflex artery.A 2.00mm x 12mm maverick 2 balloon catheter was advanced for treatment.However, upon pre-dilatation, a shaft break occurred.The device was removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).D4 - lot number: updated from 26435401 to 26406022 as per product received.Device evaluated by mfr: returned product consisted of a maverick 2 mr balloon catheter.The device was visually and microscopically examined.There was a hypotube separation 15.2cm from the strain relief.The separated ends of the hypotube were ovaled, indicating the hypotube was kinked prior to separation.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported break as there was separation to the device contributing to the reported crossing difficulty.The reported no cross in the lesion could not be confirmed as the clinical circumstances could not be replicated.
Event or Problem Description
It was reported that shaft break occurred.Vascular access was obtained via the femoral artery.The target lesion was located in the distal left circumflex artery.A 2.00mm x 12mm maverick 2 balloon catheter was advanced for treatment.However, upon pre-dilatation, a shaft break occurred.The device was removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.

• Brand Name: MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12358998
• Report Number: 2134265-2021-10719
• Device Sequence Number: 3794311
• Product Code: LOX
• UDI-Device Identifier: 08714729369967
• UDI-Public: 08714729369967
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2021

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: 11/23/2023
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0026406022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR