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	06/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the proximal and mid right coronary artery.After placing a guide wire and pre-dilatation with a 2x15mm balloon catheter, a stent could not be implanted due to calcification.A 2.5mm x 12mm quantum maverick balloon catheter was then used for dilatation.However, during inflation at 14 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Devie evaluated by mfr.: returned device consisted of a quantum maverick mr balloon catheter.The balloon was loosely folded.Analysis of the tip, balloon, inner/outer shaft, hypotube and hub included microscopic and visual inspection.Inspection revealed a burst in the balloon material that was 11mm in length.Inspection of the device found no other damage or defects.The reported burst was confirmed.
Event or Problem Description
It was reported that balloon rupture occurred.The 85% stenosed, target lesion was located in the proximal and middle of right coronary artery.On (b)(6), guide wire were crossed the lesion, pre-dilatation was performed with a 2x15mm non-bsc balloon catheter but could not be implanted due to calcified lesion.A 2.5mm x 12mm quantum maverick balloon catheter was selected for treatment.However, during inflation at 14 atmospheres, the balloon burst.The procedure was completed with another of the same device.No patient complications nor injuries reported and the patient's 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: 10215048
• Report Number: 2134265-2020-08749
• Device Sequence Number: 2404735
• Product Code: LOX
• UDI-Device Identifier: 08714729392651
• UDI-Public: 08714729392651
• 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
• Report Date (Section B): 08/17/2020

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: 10/16/2022
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0024610783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 63