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

Model Number	7010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via radial artery.After advancing a 5f non-boston scientific imaging catheter, a complete occluded lesion was noted in the ostial left anterior descending artery (lad).A 3.0mm x 12mm quantum maverick balloon catheter was selected for use.However, during first inflation at 13 atmospheres for 20 seconds, the balloon ruptured.The device was removed within the catheter and the procedure was completed with another of the same device.No patient complications were reported and the patient's status is stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 65cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was tightly folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There were no issues detected.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported balloon ruptured.
Event or Problem Description
Reportable based on the additional information received on 01dec2020.It was reported that balloon rupture occurred.Vascular access was obtained via radial artery.The target lesion was located in the left anterior descending artery (lad).A complete occulusion in ostial of lda.A 3.0mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, during first inflation at 13 atmosphere for 20 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is 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: 10998930
• Report Number: 2134265-2020-17534
• Device Sequence Number: 16341547
• Product Code: LOX
• UDI-Device Identifier: 08714729392675
• UDI-Public: 08714729392675
• 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): 02/02/2021

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: 09/24/2022
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0024488784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2020
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/13/2020
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 65