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	08/12/2020
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 was contrast in the inflation lumen and balloon and blood in the guidewire lumen.The balloon was loosely folded.Inspection of the device revealed numerous kinks throughout the hypotube and a complete hypotube separation 58cm distal of the strain relief.An inflation device filled with water was connected to the remaining distal end of the device by attaching a touhy and a stopcock to the end of the separated hypotube.When positive pressure was applied, the balloon was able to be inflated immediately with no leaks or issues.Product analysis did not confirm the reported event, as the balloon was loosely folded indicating that it was able to be inflated at the facility and during functional testing the balloon inflated to rated burst pressure with no issues immediately and fully.
Event or Problem Description
Reportable based on device analysis completed on 16-dec-2020.It was reported that slow balloon inflation occurred.The 75% stenosed target lesion was located in the middle left circumflex coronary artery.A 3.5mm x 12mm quantum maverick balloon catheter was used.However, the balloon could not fully inflate.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.However, returned device analysis revealed a shaft detachment.

• 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: 11064940
• Report Number: 2134265-2020-18349
• Device Sequence Number: 2610454
• Product Code: LOX
• UDI-Device Identifier: 08714729392699
• UDI-Public: 08714729392699
• 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): 12/23/2020

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: 07/23/2022
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0024157651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1