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

Model Number	6531
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that marker band misalignment occurred.Vascular access was obtained via femoral artery.The 80% stenosed, 32mm x 30mm, target lesion was located in the severely tortuous left anterior descending artery.A 12mm x 3.00mm nc quantum apex balloon catheter was advanced for post dilation.However, during inflation, it was noticed that the balloon marker bands were not in the right position.The proximal marker was visible in the mid of the balloon while the distal marker placed out of the inflation area.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the returned product consisted of an nc quantum apex balloon catheter.The device was microscopically and visually examined.There were numerous kinks to both the hypotube and shaft of the device.There was contrast in the inflation lumen and the balloon.The balloon was loosely folded, and the tip was damaged.The markerbands to the device were found to be misaligned.Both markerbands were positioned on the guidewire lumen.The distal markerband was into the cone-waist transition of the distal portion of the balloon.The proximal markerband was mispositioned in the center of the balloon.The markerband distance was 11mm from the most proximal point to the most distal point.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.The device was inflated to nominal pressure to determine measurement and positioning of the markerbands.A wire insertion test was also performed prior to inflation.Because the guidewire used in the procedure was not returned with the device a 0.014" guidewire was used to test the device.The wire passed through the device without resistance or issues.The wire was in place in the device prior to inflation to determine markerband placement and movement.It was determined the markerbands presented no movement and were misaligned.Inspection of the remainder of the device, presented no other damage or irregularities.
Event or Problem Description
It was reported that marker band misalignment occurred.Vascular access was obtained via femoral artery.The 80% stenosed, 32mm x 30mm, target lesion was located in the severely tortuous left anterior descending artery.A 12mm x 3.00mm nc quantum apex balloon catheter was advanced for post dilation.However, during inflation, it was noticed that the balloon marker bands were not in the right position.The proximal marker was visible in the mid of the balloon while the distal marker placed out of the inflation area.The procedure was completed with a different device.No patient complications were reported.It was further reported that the target lesion was mildly tortuous.

• 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: 11891033
• Report Number: 2134265-2021-06454
• Device Sequence Number: 14302882
• Product Code: LOX
• UDI-Device Identifier: 08714729783268
• UDI-Public: 08714729783268
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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: 11/25/2023
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0026420210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1