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

Model Number	6531
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a nc quantum apex balloon catheter.The balloon was tightly folded.Microscopic inspection on the distal shaft confirmed that the inner shaft was buckled with a hole at the distal edge of the bicomponent weld.The buckling is consistent with the technique used to remove the product mandrel and balloon protector from the device.The hole is consistent with a guidewire puncturing through the buckled location of the shaft.There was a hole in the outer shaft as well, confirming there was force applied when attempting to advance the guidewire through the catheter.
Event or Problem Description
Reportable based on analysis completed on 30-jul-2019.It was reported that difficulty loading a wire occurred.During a percutaneous coronary intervention, a 12mm x 2.50mm nc quantum apex was used but a non-bsc guidewire could not pass the device.While advancing the wire some centimeters, the wire became stuck at the entry of the device (at the end of the balloon).The event was noted to have occurred outside the patient.The device was exchanged and the procedure was completed with another of the same device.No patient complications were reported and the patient was stable following the procedure.However, returned device analysis revealed a hole in the outer shaft.

• 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: 8912670
• Report Number: 2134265-2019-09896
• Device Sequence Number: 16236215
• Product Code: LOX
• UDI-Device Identifier: 08714729783244
• UDI-Public: 08714729783244
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 08/20/2019

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: 03/26/2022
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0023547891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1