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	09/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on analysis completed on 20nov2018.It was reported that crossing difficulty was encountered.The 90% stenosed, 12mmx4mm target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 4.0mm x 12mm quantum maverick was advanced but failed to cross the lesion.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.However, returned device analysis revealed shaft detachment.Returned product consisted of a quantum maverick balloon catheter in two pieces.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube was completely separated 27.1cm from the hub.The hypotube fracture surfaces were ovaled and torn, which suggests the device was kinked prior to separation.There are numerous hypotube and shaft kinks.The tip is damaged.There is shaft damage at the exit notch that is consistent with damage seen with the use of a guidewire.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported difficulty, which could not be confirmed because the clinical circumstances could not be replicated.

• 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: 8158079
• Report Number: 2134265-2018-63998
• Device Sequence Number: 244157
• Product Code: LOX
• UDI-Device Identifier: 08714729392712
• UDI-Public: 08714729392712
• 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): 12/12/2018

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: 02/07/2021
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0021722950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 72