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

Model Number	7575
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.Vascular access was obtained via the right femoral artery.The 90% stenosed, 16mm in length, eccentric, de novo target lesion with a bend of >45 and <90 degrees was located in the moderately tortuous and mildly calcified left circumflex artery with a 3.00mm vessel diameter.After a 6f ebu 3.5 guide catheter was engaged and a non-boston scientific guidewire crossed the lesion, a 2.50mm x 9mm maverick balloon catheter was attempted to be inserted into the guide catheter.However, while negotiating the balloon catheter, the shaft broke at approximately 24cm from the hub.The device was removed and the procedure was completed with a 2.00mm x 9mm maverick balloon catheter.There were no patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 21.5cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was tightly folded.Microscopic inspection revealed tip damage.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported broken shaft as the hypotube was separated.
Event or Problem Description
It was reported that shaft break occurred.Vascular access was obtained via the right femoral artery.The 90% stenosed, 16mm in length, eccentric, de novo target lesion with a bend of >45 and <90 degrees was located in the moderately tortuous and mildly calcified left circumflex artery with a 3.00mm vessel diameter.After a 6f ebu 3.5 guide catheter was engaged and a non-boston scientific guidewire crossed the lesion, a 2.50mm x 9mm maverick balloon catheter was tried to insert in the guide catheter.However, while negotiating the balloon catheter, the shaft broke at approximately 24cm from the hub.The device was removed and the procedure was completed with 2.00mm x 9mm maverick balloon catheter.There were no patient complications reported and the patient's 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: 10968232
• Report Number: 2134265-2020-17153
• Device Sequence Number: 4168806
• Product Code: LOX
• UDI-Device Identifier: 08714729369899
• UDI-Public: 08714729369899
• 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): 02/03/2021

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: 08/01/2022
• Device Model Number: 7575
• Device Catalogue Number: 7575
• Device Lot Number: 0024206182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Received by Manufacturer: 11/21/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER (6F EBU 3); GUIDE CATHETER (6F EBU 3); GUIDEWIRE (BMW); GUIDEWIRE (BMW); GUIDE CATHETER (6F EBU 3); GUIDEWIRE (BMW)
• Patient Age: 63 YR
• Patient Weight: 78