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

Model Number	7005
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
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 18.1cm distal of the strain relief and another separation 67.5cm distal from there.The distal portion of the device was missing.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on analysis completed on 13-aug-2019.It was reported that shaft kink occurred.The 85% stenosed, 8x3.5mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 3.5mm x 8mm quantum maverick balloon catheter was advanced for dilatation.However, the hypotube was kinked after entering the guide catheter.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed shaft detachment.

• 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: 8966530
• Report Number: 2134265-2019-10762
• Device Sequence Number: 2151267
• Product Code: LOX
• UDI-Device Identifier: 08714729392583
• UDI-Public: 08714729392583
• 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
• Report Date (Section B): 09/05/2019

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: 11/06/2021
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0022906843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 71