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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in a mildly tortuous and mildly calcified proximal end of the left anterior descending artery.After a 3.5 non-boston scientific (bsc) sheath was placed in the ostium of the left coronary artery (lca) and a non-bsc guidewire crossed the lesion, a 2.5-20 non-bsc balloon catheter was advanced for predilatation and was followed by implantation of a 3.0-24 non-bsc stent.Subsequently, a 3.0mm x 12mm quantum maverick balloon catheter was advanced for post-dilatation.However, during initial inflation, the balloon ruptured.Post-dilatation was performed with another of the same device and the stent was well apposed to the vessel.Timi 3 flow was established and the procedure was completed.There were no patient complications reported and the patient status was 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.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.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in a mildly tortuous and mildly calcified proximal end of the left anterior descending artery.After a 3.5 non-boston scientific (bsc) sheath was placed in the ostium of the left coronary artery (lca) and a non-bsc guidewire crossed the lesion, a 2.5-20 non-bsc balloon catheter was advanced for predilatation and was followed by implantation of a 3.0-24 non-bsc stent.Subsequently, a 3.0mm x 12mm quantum maverick balloon catheter was advanced for post-dilatation.However, during initial inflation, the balloon ruptured.Post-dilatation was performed with another of the same device and the stent was well apposed to the vessel.Timi 3 flow was established and the procedure was completed.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: 11146874
• Report Number: 2134265-2020-18624
• Device Sequence Number: 11677102
• 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): 02/18/2021

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: 05/21/2022
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0023833282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Received by Manufacturer: 12/24/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 80