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

Model Number	7005
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter in two pieces.The balloon was loosely folded with blood in the inflation lumen (shaft).The tip, balloon, inner/outer shaft, and hypotube were microscopically and visually inspected.Inspection revealed numerous kinks in the hypotube with a fracture in the hypotube located 84.2cm from the tip of the device.The fracture faces were ovalized, as if kinked prior to separating.Inspection of the rest of the device found no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2019.It was reported that crossing difficulties were encountered.Vascular access was obtained via the femoral artery.The 85% stenosed, 20x3.0mm, eccentric, de novo target lesion with a bend of more than or equal to 90 degrees was located in the non-tortuous and non-calcified mid right coronary artery.After crossing a guide wire, a 3.0mm x 8mm quantum maverick balloon catheter was advanced for pre-dilatation but the device 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 shaft fracture.

• 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: 8732905
• Report Number: 2134265-2019-07404
• Device Sequence Number: 11209568
• Product Code: LOX
• UDI-Device Identifier: 08714729392569
• UDI-Public: 08714729392569
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: 11/21/2020
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0021423887
• 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