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

Model Number	7010
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned device consisted of a quantum maverick balloon catheter in two pieces.The balloon was tightly folded.The tip, balloon, inner/outer shaft, port/exit notch and hypotube were microscopically and visually inspected.Inspection revealed numerous kinks in the hypotube and a complete separation in the shaft (at the port/exit notch) located 24.5 cm from the tip of the device.The fracture faces of the separated ends were focally necked.The rest of the device was inspected, and no other damage or irregularities were found.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2019.It was reported that shaft kink occurred.During unpacking of a 2.5 mm x 12 mm quantum maverick balloon catheter, it was noted that the shaft was kinked.The procedure was completed with another of the same device.No patient complications were reported and patient 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: 8848675
• Report Number: 2134265-2019-09078
• Device Sequence Number: 2717057
• 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
• Report Date (Section B): 07/31/2019

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: 01/17/2022
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0023209910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/31/2019
• 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: 70