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

Model Number	7005
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left anterior descending artery.A 2.5mm x 8mm quantum maverick balloon catheter was advanced and was able to reach the lesion.However, during inflation, the balloon failed to inflate and it was noted that the balloon ruptured.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 target lesion was located in the left anterior descending artery.A 2.5mm x 8mm quantum maverick balloon catheter was advanced and was able to reach the lesion.However, during inflation, the balloon failed to inflate and it was noted that the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.It was further reported that the balloon was inflated twice and the balloon ruptured at 18 atmospheres for 5 seconds.The device was completely removed from the patient's body.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of the quantum maverick balloon catheter.The device was microscopically and visually examined.There were numerous kinks in the hypotube.There was separation of the hypotube at 79.1cm from strain relief.The separated ends of the hypotube were oval shaped indicating that the device was kinked prior to separation.There was contrast in the inflation lumen, balloon, and balloon folds.There was blood present in the guidewire lumen.The balloon was tightly folded.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 to rated burst pressure, as well as deflate with no issues.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left anterior descending artery.A 2.5mm x 8mm quantum maverick balloon catheter was advanced and was able to reach the lesion.However, during inflation, the balloon failed to inflate and it was noted that the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.It was further reported that the balloon was inflated twice and the balloon ruptured at 18 atmospheres for 5 seconds.The device was completely removed from the patient's body.

• 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: 11638532
• Report Number: 2134265-2021-04549
• Device Sequence Number: 3396767
• Product Code: LOX
• UDI-Device Identifier: 08714729392545
• UDI-Public: 08714729392545
• 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,Followup
• Report Date (Section B): 06/01/2021

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: 01/09/2023
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0025023139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 04/08/2021; 05/18/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 04/19/2021; 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 76