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

Model Number	7010
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on analysis completed on 20-nov-2018.It was reported that the balloon failed to inflate.Vascular access was obtained via the femoral artery.The concentric target lesion contained a bend >=90 degrees and was located in the mildly calcified distal right coronary artery.A 2.0mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, the balloon failed to inflated.The procedure was completed using another balloon with buddy wire support.No patient complications were reported and the patient was doing well.However, returned device analysis revealed shaft detachment.Device evaluated by manufacturer: the returned product consisted of a quantum maverick balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.The balloon was tightly folded.There were numerous hypotube kinks throughout the device.There was a complete hypotube separation 19.2cm distal of the strain relief.The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation.Functional testing was performed by attaching inflation device filled water to the remaining distal end of the device by attaching a toughy and a stopcock to the fractured hypotube.The device was inflated to the rated burst pressure and the catheter maintained constant pressure.There was no indication of any leaks or other irregularities in the balloon.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 8156243
• Report Number: 2134265-2018-63845
• Device Sequence Number: 13876604
• Product Code: LOX
• UDI-Device Identifier: 08714729392637
• UDI-Public: 08714729392637
• 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): 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: 02/08/2021
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0021727412
• 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: 45 YR
• Patient Weight: 52