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

Model Number	7015
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the left anterior descending artery.A 2.75mm x 15mm quantum maverick balloon catheter was advanced for dilatation, however, during initial inflation at 15 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the returned product consisted of the quantum maverick balloon catheter.The device was microscopically and visually examined.There were numerous kinks and bends in the hypotube.The hub was not returned with device as it was separated at strain relief.There was separation of the hypotube at 47.4cm from strain relief.The separated ends of the hypotube were oval shaped indicating that the device was kinked prior to separation.Blood was present in the guidewire lumen and in the folds of the balloon.The balloon was tightly folded and had tip damage.From the separation, the distal end of the device was connected to a toughy and prepped with an inflation device filled with water to inflate the device to the rated burst.The balloon was able to be inflated and maintained pressure as well as deflate with no issues.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the left anterior descending artery.A 2.75mm x 15mm quantum maverick balloon catheter was advanced for dilatation, however, during initial inflation at 15 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.

• Brand Name: QUANTUM 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: 11358937
• Report Number: 2134265-2021-01824
• Device Sequence Number: 3383543
• Product Code: LOX
• UDI-Device Identifier: 08714729392774
• UDI-Public: 08714729392774
• 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,Followup
• Report Date (Section B): 05/06/2021

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: 11/11/2022
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0024753325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 70