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

Model Number	6532
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft damage occurred.The target lesion was located in the left anterior descending artery.A 15mm x 2.75mm nc quantum apex balloon catheter was used for dilatation.However, during the start of inflation, the shaft ruptured and blood went back into the indeflator.The device was completely removed and the procedure was completed using a new wire and a 2.5 x 15 nc quantum aprex balloon catheter.No patient complications were reported.
Event or Problem Description
It was reported that shaft damage occurred.The target lesion was located in the left anterior descending artery.A 15mm x 2.75mm nc quantum apex balloon catheter was used for dilatation.However, during the start of inflation, the shaft ruptured and blood went back into the indeflator.The device was completely removed and the procedure was completed using a new wire and a 2.5 x 15 nc quantum aprex balloon catheter.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a nc quantum apex balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube, inflation lumen, and guidewire lumen.The hypotube is separated 73.9cm from the hub and appears to have been kinked prior to separation.Microscopic examination revealed no additional damages.There is blood present in the inflation lumen, guidewire lumen, and hub.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found a separation of the hypotube.

• 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: 8500999
• Report Number: 2134265-2019-03724
• Device Sequence Number: 1884684
• Product Code: LOX
• UDI-Device Identifier: 08714729783367
• UDI-Public: 08714729783367
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/24/2019

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: 12/11/2021
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0023070931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1