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

Model Number	7015
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 66.6cm distal of the strain relief.There was contrast in the inflation lumen.The balloon was tightly folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.The device was tested with an inflation device filled with water and was able to inflate to rated burst pressure and deflate with no difficulties.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported difficulties inflating the balloon.
Event or Problem Description
Reportable based on device analysis completed on 16-sep 2020.It was reported that inflation failure occurred.The 90% stenosed, 20mm x 4.5mm target lesion was located in the mildly tortuous and severely calcified right coronary artery.A 3.5mm x 15mm quantum maverick balloon catheter was advanced for dilatation.However, during procedure the physician found the stent could not stick well to the vessel as the balloon failed to inflate.The procedure was completed with another of same device.There were no patient's complications nor injuries reported and the patient's status was stable.However, returned device analysis revealed shaft detached/separated.

• 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: 10638016
• Report Number: 2134265-2020-13057
• Device Sequence Number: 3159063
• Product Code: LOX
• UDI-Device Identifier: 08714729392804
• UDI-Public: 08714729392804
• 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): 10/06/2020

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: 10/10/2022
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0024580586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 59