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

Model Number	7590
Medical Device Problem Codes	Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the severely calcified mid left anterior descending artery.A 1.50mm x 20mm maverick balloon catheter was advanced for dilatation where a kink was observed in the device.During second inflation at 12 atmospheres for 21-22 seconds, the balloon ruptured.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the severely calcified mid left anterior descending artery.A 1.50mm x 20mm maverick balloon catheter was advanced for dilatation where a kink was observed in the device.During second inflation at 12 atmospheres for 21-22 seconds, the balloon ruptured.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a maverick 2mr balloon catheter.The device was microscopically and visually examined.There was contrast in the inflation lumen and the balloon was tightly folded.The balloon had a hole (less than 1mm in length) 8mm from the tip of the device.There was a kink in the tip transition of the device and the tip was damaged.Product analysis confirmed the reported event, as the device was found to have a hole as well as kink damage to the balloon.

• 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: 11638401
• Report Number: 2134265-2021-04543
• Device Sequence Number: 3396766
• Product Code: LOX
• UDI-Device Identifier: 08714729370154
• UDI-Public: 08714729370154
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 05/17/2021

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: 07/08/2021
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0022346191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR