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

Model Number	6531
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.A 12mm x 2.50mm nc quantum apex was used during a percutaneous coronary intervention procedure.The nc quantum apex was advanced over an unknown guidewire.During removal, it was noted that it was not possible to withdraw the balloon without the wire.The devices were stuck together.The procedure was completed with another of the same device.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a nc quantum apex balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.An unknown guidewire was with the device.There were numerous kinks.There was a complete separation at 3mm distal of the exit notch.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.The proximal portion of the device was stuck on a guidewire.The inner shaft between the marker bands was buckled down.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that device entrapment occurred.A 12mm x 2.50mm nc quantum apex was used during a percutaneous coronary intervention procedure.The nc quantum apex was advanced over an unknown guidewire.During removal, it was noted that it was not possible to withdraw the balloon without the wire.The devices were stuck together.The procedure was completed with another of the same device.There were no patient complications.

• Brand Name: NC QUANTUM APEX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10078707
• Report Number: 2134265-2020-06639
• Device Sequence Number: 2823384
• Product Code: LOX
• UDI-Device Identifier: 08714729783244
• UDI-Public: 08714729783244
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2020

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: 11/17/2022
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0024783756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1