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

Model Number	6529
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc quantum apex balloon catheter.The balloon was loosely folded, with fluid in the balloon.The tip, balloon, inner/outer shafts and hypotube were microscopically and visually inspected.Inspection revealed shaft damage (numerous perforations) for a length of 52mm from the tip of the device.Inspection of the remainder of the device found no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported crossing difficulty.
Event or Problem Description
Reportable based on device analysis completed on 02-jan-2019.It was reported that crossing difficulties were encountered.Vascular access was obtained via the femoral artery.The target lesion was located in the severely tortuous and moderately calcified left circumflex artery.A 6mm x 2.75mm nc quantum apex balloon catheter was advanced for pre-dilatation.However, the device failed to cross the lesion due to the tortuousity.Pre-dilatation was performed with a smaller diameter and shorter length balloon, followed by the implantation of a stent and the procedure was completed.No patient complications were reported and the patient was doing all right.However, device analysis revealed numerous shaft perforations.

• 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: 8272639
• Report Number: 2134265-2019-00313
• Device Sequence Number: 11071206
• Product Code: LOX
• UDI-Device Identifier: 08714729783039
• UDI-Public: 08714729783039
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2019

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: 11/14/2020
• Device Model Number: 6529
• Device Catalogue Number: 6529
• Device Lot Number: 0021393679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1