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

Model Number	6532
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the shaft broke.The target lesion was located in the left anterior descending artery (lad).A 3.5x16mm synergy stent was successful deployed in the lad, however, it was noted that a plaque shift into the diagonal occurred.A second wire was then placed in the diagonal with the stent delivery system still placed in the lad.A 15mm x 2.25mm nc quantum apex balloon catheter was advanced; however, the device met resistance inside the guide with the stent delivery system along with the two wires inside the guide catheter.The physician pulled back the nc quantum apex balloon catheter but the shaft separated at the monorail junction inside the guide catheter.The physician was able to utilize the stent delivery system to pull it back into the guide and removed everything from the patient.The same two wires with two different balloons were used to complete the procedure using a kissing balloon technique.No patient complications were reported and the patient did well.
Event or Problem Description
It was reported the shaft broke.The target lesion was located in the left anterior descending artery (lad).A 3.5x16mm synergy stent was successful deployed in the lad, however, it was noted that a plaque shift into the diagonal occurred.A second wire was then placed in the diagonal with the stent delivery system still placed in the lad.A 15mm x 2.25mm nc quantum apex balloon catheter was advanced; however, the device met resistance inside the guide with the stent delivery system along with the two wires inside the guide catheter.The physician pulled back the nc quantum apex balloon catheter but the shaft separated at the monorail junction inside the guide catheter.The physician was able to utilize the stent delivery system to pull it back into the guide and removed everything from the patient.The same two wires with two different balloons were used to complete the procedure using a kissing balloon technique.No patient complications were reported and the patient did well.
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 a kink on the hypotube 81.5cm from the hub.There is a kink on the inflation lumen and guidewire lumen 11.7cm from the tip.Microscopic examination revealed that the tip is damaged.There is buckling to the balloon and guidewire lumen 4mm from the tip and approximately 14mm long.There is buckling to the inflation lumen and guidewire lumen 21mm from the tip and approximately 19mm long.There is contrast present in the hub and inflation lumen.The balloon is loosely folded.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: 8330852
• Report Number: 2134265-2019-00909
• Device Sequence Number: 53624
• Product Code: LOX
• UDI-Device Identifier: 08714729783343
• UDI-Public: 08714729783343
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/05/2019

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: 04/09/2021
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0021970005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR