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

Model Number	7015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 95% stenosed, 28mm x 3.0mm target lesion was located in the mildly tortuous and calcified left anterior descending artery.A 3.25mm x 15mm quantum maverick balloon catheter was advanced for dilatation.However, it was noted that the delivery shaft of balloon was fractured.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
Event or Problem Description
It was reported that shaft break occurred.The 95% stenosed, 28mm x 3.0mm target lesion was located in the mildly tortuous and calcified left anterior descending artery.A 3.25mm x 15mm quantum maverick balloon catheter was advanced for dilatation.However, it was noted that the delivery shaft of balloon was fractured.The procedure was completed with another of the same device.There were no patient complications reported and the patient's 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.There was a kink 77.6cm distal from the strain relief and a shaft kink 17.5cm proximal from the tip.There was a complete separation at 81cm distal of the strain relief.There was contrast in the inflation lumen and the balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 8678691
• Report Number: 2134265-2019-05849
• Device Sequence Number: 16608822
• Product Code: LOX
• UDI-Device Identifier: 08714729392798
• UDI-Public: 08714729392798
• 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): 07/05/2019

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: 11/15/2021
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0022953312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/05/2019
• 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