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

Model Number 7590

Device Problem Material Rupture (1546)

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

Event Date 11/22/2021

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the moderately tortuous and moderately calcified mid left anterior descending artery.A 1.50mm x 20mm maverick balloon catheter was advanced for dilatation.However, during inflation, the pressure did not rise to more than 10 atmospheres.Upon checking, a small hole in the marker was found.The device was completely removed and the procedure was completed with another of same device.No patient complications were reported and the patient condition was stable.

Manufacturer Narrative

Returned product consisted of a maverick 2mr balloon catheter.The device was visually and microscopically examined.There were numerous kinks to the hypotube of the device.There was contrast present in the inflation lumen and balloon.The balloon was loosely folded, and the tip of the device was damaged.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole in the balloon located 15mm from the tip of the device.The device failed to inflate to rated burst pressure.Product analysis confirmed the reported event, as during functional testing the device was found to have a pinhole damage to the balloon.

Event Description

It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the moderately tortuous and moderately calcified mid left anterior descending artery.A 1.50mm x 20mm maverick balloon catheter was advanced for dilatation.However, during inflation, the pressure did not rise to more than 10 atmospheres.Upon checking, a small hole in the marker was found.The device was completely 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12884729
• MDR Text Key: 281351244
• Report Number: 2134265-2021-14952
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729370154
• UDI-Public: 08714729370154
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2024
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0026717358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male