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

Model Number	6532
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in ostial circumflex artery.A 15mm x 3.25mm nc quantum apex balloon catheter was advanced but failed to cross the lesion.When removal was attempted, it was noted that the device became stuck.The physician pulled the device and split the balloon in half.The device was removed but the broken portion remained in the body.The guide wire was then pulled out and luckily, the broken portion came out along with it.No patient complications were reported.
Additional Manufacturer Narrative
Patient height: 177.8cm.Device evaluated by mfr.: returned product consisted of a nc quantum apex balloon catheter.The returned device was visually and microscopically examined.Visual examination revealed that the distal section of the device is missing.The missing parts are the distal guidewire lumen, distal inflation lumen, marker bands, balloon, and tip.There are multiple kinks along the whole device.The inflation lumen and guidewire lumen are separated 126.5cm from the hub.The separation appears to have been stretched prior to separating.Microscopic examination revealed a longitudinal tear of the inflation lumen and guidewire lumen from the exit notch to the separation.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in ostial circumflex artery.A 15mm x 3.25mm nc quantum apex balloon catheter was advanced but failed to cross the lesion.When removal was attempted, it was noted that the device became stuck.The physician pulled the device and split the balloon in half.The device was removed but the broken portion remained in the body.The guide wire was then pulled out and luckily, the broken portion came out along with it.No patient complications were reported.

• 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: 7955682
• Report Number: 2134265-2018-61838
• Device Sequence Number: 16420267
• Product Code: LOX
• UDI-Device Identifier: 08714729783381
• UDI-Public: 08714729783381
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 01/28/2019

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: 04/17/2021
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0022008523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 87