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 Consequences Or Impact To Patient (2199)
Date of Event	04/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon pinhole occurred.The 80% stenosed, 20mmx2.75mm target lesion was located in the severely tortuous and moderately calcified left anterior descending artery.A 2.75mm x 8mm quantum maverick balloon catheter was advanced for dilatation.However, during the first inflation attempt, the balloon failed to inflate due to a pinhole on the balloon.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.
Additional Manufacturer Narrative
Device 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 and hypotube included microscopic and visual inspection.Inspection revealed a pinhole in the balloon material located 11mm from the tip of the device.Inspection of the rest of the device found no other damage or defect.
Event or Problem Description
It was reported that balloon pinhole occurred.The 80% stenosed, 20mmx2.75mm target lesion was located in the severely tortuous and moderately calcified left anterior descending artery.A 2.75mm x 8mm quantum maverick balloon catheter was advanced for dilatation.However, during the first inflation attempt, the balloon failed to inflate due to a pinhole on the balloon.The procedure was completed with another of the same device.No patient complications were reported and the patient 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: 10093707
• Report Number: 2134265-2020-06072
• Device Sequence Number: 14326994
• Product Code: LOX
• UDI-Device Identifier: 08714729392552
• UDI-Public: 08714729392552
• 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): 06/25/2020

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: 03/17/2022
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0023499463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 75