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

Model Number	7010
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The balloon was loosely folded with blood in the balloon, inflation lumen (shaft) and wire lumen (shaft).The tip, balloon, inner/outer shaft, and hypotube were microscopically and visually inspected.Inspection revealed tip damage, numerous kinks in the hypotube, and pinholes in the balloon material located 1mm distal of the proximal markerband.Inspection of the rest of the device found no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 31-may-2019.It was reported that crossing difficulties were encountered.The 90% stenosed, 12x2.75mm target lesion was located in the moderately tortuous and calcified right coronary artery.A 2.75mm x 12mm quantum maverick balloon catheter was advanced but failed to cross the lesion.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed balloon pinhole.

• 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: 8733015
• Report Number: 2134265-2019-07425
• Device Sequence Number: 2271501
• Product Code: LOX
• UDI-Device Identifier: 08714729392668
• UDI-Public: 08714729392668
• 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): 06/25/2019

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: 11/04/2021
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0022889577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 79