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

Model Number 7590

Device Problems Material Rupture (1546); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2021

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the severely tortuous and severely calcified mid left anterior descending artery.A 2.00mm x 20mm maverick balloon catheter was advanced for dilatation.The balloon was inflated twice at 12 atmospheres for 21-22 seconds.However, during the second inflation, the balloon ruptured.It was further noted that the device was kinked due to angulation when crossing the lesion.The device was removed and the procedure was completed with another of same device.No patient complications were reported and the patient condition was stable.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a maverick 2mr balloon catheter.The device was visually and microscopically examined.At 20cm from the strain relief the hypotube was kinked.There was contrast and blood in the inflation lumen.There was blood in the guidewire lumen.The balloon was loosely folded with contrast present in the balloon.At 5mm from the tip of the device there was a longitudinal tear for a length of 12mm running proximal to the tip.The tip of the device was also damaged.Product analysis confirmed the reported events as the device was kinked and had a longitudinal tear.

Event Description

It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the severely tortuous and severely calcified mid left anterior descending artery.A 2.00mm x 20mm maverick balloon catheter was advanced for dilatation.The balloon was inflated twice at 12 atmospheres for 21-22 seconds.However, during the second inflation, the balloon ruptured.It was further noted that the device was kinked due to angulation when crossing the lesion.The device was removed and the procedure was completed with another of same device.No patient complications were reported and the patient condition 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: 12407846
• MDR Text Key: 269469995
• Report Number: 2134265-2021-11086
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729370161
• UDI-Public: 08714729370161
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2023
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0026395343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR