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

Model Number	6532
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at the time of event: 18 years or older.
Event or Problem Description
It was reported that catheter entrapment occurred.Vascular access was obtained via the femoral artery.The concentric target lesion was located in the left anterior descending artery.A 15mm x 3.00mm nc quantum apex balloon catheter was advanced for post-dilatation.However, after the balloon was deflated, the physician attempted to remove the device, but it became stuck with the wire.The physician then decided to remove the whole system and the procedure was completed.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that catheter entrapment occurred.Vascular access was obtained via the femoral artery.The concentric target lesion was located in the left anterior descending artery.A 15mm x 3.00mm nc quantum apex balloon catheter was advanced for post-dilatation.However, after the balloon was deflated, the physician attempted to remove the device, but it became stuck with the wire.The physician then decided to remove the whole system and the procedure was completed.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Age at the time of event: 18 years or older.Device evaluated by mfr.: returned product consisted of a nc quantum apex balloon catheter in two pieces.The balloon was loosely folded, and the device was bloody.Analysis of the balloon, inner/outer shaft, port/exit notch, and hypotube included microscopic and visual inspection.Inspection revealed numerous kinks in the hypotube, and the shaft separated at the port/exit notch (24.5cm from tip) with distal shaft damage (accordioned) for approximately 3cm.The separated ends appeared stretched, as if excessive tensile force was put on the area prior to separating.Functional testing with a guide wire could not be done due to the damage to the device.The reported wire difficulty could not be confirmed via lab analysis.

• 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: 9531462
• Report Number: 2134265-2019-16130
• Device Sequence Number: 2313472
• Product Code: LOX
• UDI-Device Identifier: 08714729783374
• UDI-Public: 08714729783374
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: 05/16/2022
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0023807960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1