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

Model Number 6532

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2019

Event Type  malfunction  

Event 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 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.

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
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8500999
• MDR Text Key: 141509409
• Report Number: 2134265-2019-03724
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729783367
• UDI-Public: 08714729783367
• Combination Product (y/n): N
• PMA/PMN Number: K121667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1