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

Model Number	6534
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon removal difficulties were encountered.A 30mm x 2.50mm nc quantum apex balloon catheter was advanced for dilation.However, when the balloon was attempted to be removed following deflation, the balloon did not slide easily and became stuck to the guide.After several attempts, the physician managed to withdraw the balloon.No patient complications were reported.
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 multiple kinks along the whole device.Microscopic examination revealed that the tip is damaged and the balloon is loosely folded.The guide wire used in the clinical procedure was not returned with the device so a test guide wire was used for functional testing.Per product specification, a 0.014 test guidewire was inserted into the device.The device was inflated to rated burst pressure of 20atm and then deflated to replicate the customers statement.The test guide wire could be removed without any difficulties.Because there was no evidence of any product quality deficiencies, it was considered likely that the kinks and damaged tip were attributable to the procedure; therefore, the cause code adverse event related to procedure was used for this damage.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the reported sticking to the guidewire.
Event or Problem Description
It was reported that balloon removal difficulties were encountered.A 30mm x 2.50mm nc quantum apex balloon catheter was advanced for dilation.However, when the balloon was attempted to be removed following deflation, the balloon did not slide easily and became stuck to the guide.After several attempts, the physician managed to withdraw the balloon.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: 8067144
• Report Number: 2134265-2018-62723
• Device Sequence Number: 11360147
• Product Code: LOX
• UDI-Device Identifier: 08714729783572
• UDI-Public: 08714729783572
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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: 08/19/2021
• Device Model Number: 6534
• Device Catalogue Number: 6534
• Device Lot Number: 0022539944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1