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

Model Number 7575

Device Problems Break (1069); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2020

Event Type  malfunction  

Event 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.

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 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
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10968232
• MDR Text Key: 220225109
• Report Number: 2134265-2020-17153
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729369899
• UDI-Public: 08714729369899
• Combination Product (y/n): N
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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