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

Model Number 7585

Device Problem Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2020

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The target lesion was located in a coronary vessel.A 2.00mm x 15mm maverick 2 balloon catheter was advanced for dilatation.However, during inflation at 12 atmospheres, the balloon ruptured.The procedure was completed with a different device.No complications were reported.

Event Description

It was reported that balloon rupture occurred.The target lesion was located in a coronary vessel.A 2.00mm x 15mm maverick 2 balloon catheter was advanced for dilatation.However, during inflation at 12 atmospheres, the balloon ruptured.The procedure was completed with a different device.No complications were reported.It was also further reported that the 75% stenosed target lesion was located in the non tortuous and non calcified left anterior descending artery.The balloon was inflated three times at 18 atmospheres for 15 seconds.No interventions were performed in response to the issue and the patient status is fine.

• 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: 9703690
• MDR Text Key: 179754625
• Report Number: 2134265-2020-01408
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729370062
• UDI-Public: 08714729370062
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2022
• Device Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0024133375
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR