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

Model Number	6534
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The 95% stenosed target lesion was located in the mildly tortuous and severely calcified mid left anterior descending artery.A 30mm x 2.50mm nc quantum apex balloon catheter was advanced for dilation.During removal, the distal portion remained in patient due to a bend.The device was completely removed by trapping the wire and inflating another balloon.The procedure was completed with another of the same device and no further complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The 95% stenosed target lesion was located in the mildly tortuous and severely calcified mid left anterior descending artery.A 30mm x 2.50mm nc quantum apex balloon catheter was advanced for dilation.During removal, the distal portion remained in patient due to a bend.The device was completely removed by trapping the wire and inflating another balloon.The procedure was completed with another of the same device and no further complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 56.8cm distal of the strain relief.The was blood in the guidewire lumen.The balloon was tightly folded.Microscopic inspection revealed tip damage.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 10757988
• Report Number: 2134265-2020-14604
• Device Sequence Number: 11733445
• Product Code: LOX
• UDI-Device Identifier: 08714729783572
• UDI-Public: 08714729783572
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 6534
• Device Catalogue Number: 6534
• Device Lot Number: 0025653715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention