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

Model Number 6532

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

Age at the time of event: 18 years or older.

Event 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 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.

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
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9531462
• MDR Text Key: 177150604
• Report Number: 2134265-2019-16130
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729783374
• UDI-Public: 08714729783374
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1