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

Model Number	7010
Medical Device Problem Codes	Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a coronary artery.A 3.75mm x 12mm quantum maverick balloon catheter was selected for use.However, it was noted that the balloon was fractured.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
(b5) describe event or problem updated.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the chest.A 3.75mm x 12mm quantum maverick balloon catheter was selected for use.However, it was noted that the balloon was fractured.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that the shaft of the catheter was kinked and not a balloon rupture as what was previously reported.The device was removed within the guidecather and completely removed from the patients body.
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 61cm distal of the strain relief.There was no distal portion of the device.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 target lesion was located in the chest.A 3.75mm x 12mm quantum maverick balloon catheter was selected for use.However, it was noted that the balloon was fractured.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that the shaft of the catheter was kinked and not a balloon rupture as what was previously reported.The device was removed within the guidecather and completely removed from the patients 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: 10720662
• Report Number: 2134265-2020-14186
• Device Sequence Number: 19598287
• Product Code: LOX
• UDI-Device Identifier: 08714729392705
• UDI-Public: 08714729392705
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2020

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: 12/18/2022
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0024956322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 10/15/2020; 11/17/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 11/02/2020; 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 80