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

Model Number	7580
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned product consisted of a maverick 2mr balloon catheter.The device was microscopically and visually examined.There was both contrast and blood in the inflation lumen and balloon.There was blood in the guidewire lumen and the balloon was loosely folded.The device was soaked for a period of time to help break up the contrast and blood and was then 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 5mm from the tip of the device near the distal markerband.There was no visible markerband damage to the device.The device failed to inflate to rated burst pressure.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2021.It was reported that the device was damaged.The 70% stenosed target lesion was located in the mid left anterior descending artery.A 2.00mm x 12mm maverick balloon catheter was selected for use.However, during unpacking, the device was noted to be damaged.The procedure was completed with another of same device.No patient complications were reported and the patient was stable.However, returned device analysis revealed the device had been inside the patient and had a balloon pinhole.

• 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: 12415616
• Report Number: 2134265-2021-10928
• Device Sequence Number: 11856539
• Product Code: LOX
• UDI-Device Identifier: 08714729369967
• UDI-Public: 08714729369967
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 09/02/2021

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: 05/01/2023
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0025485974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 58