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

Model Number	6533
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone (b)(6).
Event or Problem Description
It was reported the balloon froze on the wire.The 70% stenosed target lesion was located in the mildly tortuous and none calcified left anterior descending artery (lad).A 20mm x 3.00mm nc quantum apex was used during a percutaneous coronary intervention procedure.The physician prepared the balloon as normal, placed the balloon over the wire normally from the balloon tip until the end of the over-the-wire (otw) part of the shaft.It was easy to push the balloon through the guiding catheter.Suddenly, when reaching the left main, the physician felt a strange resistance.During removal, it was noted that it was not possible to withdraw the balloon without the wire.The wire was not in the true lumen of the shaft anymore.The wire passed into the lumen distal to the balloon.The devices were stuck together.The balloon was removed with the guidewire by withdraw in the guiding catheter.The procedure was completed with another 20mm x 3.00mm nc quantum apex.There were no patient complications.
Additional Manufacturer Narrative
E1: initial reporter phone (b)(6).
Event or Problem Description
It was reported the balloon froze on the wire.The 70% stenosed target lesion was located in the mildly tortuous and none calcified left anterior descending artery (lad).A 20mm x 3.00mm nc quantum apex was used during a percutaneous coronary intervention procedure.The physician prepared the balloon as normal, placed the balloon over the wire normally from the balloon tip until the end of the over-the-wire (otw) part of the shaft.It was easy to push the balloon through the guiding catheter.Suddenly, when reaching the left main, the physician felt a strange resistance.During removal, it was noted that it was not possible to withdraw the balloon without the wire.The wire was not in the true lumen of the shaft anymore.The wire passed into the lumen distal to the balloon.The devices were stuck together.The balloon was removed with the guidewire by withdraw in the guiding catheter.The procedure was completed with another 20mm x 3.00mm nc quantum apex.There were no patient complications.It was further reported that the patient was stable without any impact.The wire was used a non-boston scientific wire.
Event or Problem Description
It was reported the balloon froze on the wire.The 70% stenosed target lesion was located in the mildly tortuous and none calcified left anterior descending artery (lad).A 20mm x 3.00mm nc quantum apex was used during a percutaneous coronary intervention procedure.The physician prepared the balloon as normal, placed the balloon over the wire normally from the balloon tip until the end of the over-the-wire (otw) part of the shaft.It was easy to push the balloon through the guiding catheter.Suddenly, when reaching the left main, the physician felt a strange resistance.During removal, it was noted that it was not possible to withdraw the balloon without the wire.The wire was not in the true lumen of the shaft anymore.The wire passed into the lumen distal to the balloon.The devices were stuck together.The balloon was removed with the guidewire by withdraw in the guiding catheter.The procedure was completed with another 20mm x 3.00mm nc quantum apex.There were no patient complications.It was further reported that the patient was stable without any impact.The wire was used a non-boston scientific wire.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an nc quantum apex balloon catheter with a non-boston scientific wire.The visual inspection revealed that there were numerous kinks to the hypotube and shaft of the device.There was contrast and blood in the inflation lumen and blood in the balloon.Microscopic examination showed that the inflation lumen was punctured at 63mm from the tip and the guidewire lumen was punctured at 69mm from the tip.There was a bend/kink of the shaft and guidewire at 88mm from the tip.The tip of the device was damaged.A non-boston scientific guidewire was returned within the complaint device and was not moveable.The outer diameter (od) of the returned non-boston scientific guidewire was measured with a calibrated laser micrometer.The od was 0.0134 inch, which was within specification for guidewire use with the returned device per nc quantum apex product specification.The non-boston scientific wire was not moveable and the puncture hole to both lumens would cause resistance and difficulty with wire advancement or movement.The unreported shaft bend would also cause resistance to wire movement.The shaft punctures, shaft kink, and tip damage on the device is consistent with the damage likely from difficulty loading a guidewire which can be caused by interaction with the guidewire.Inspection of the remainder of the device, revealed no damage or irregularities.E1: initial reporter phone -(b)(6).

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13024847
• Report Number: 2134265-2021-15935
• Device Sequence Number: 1766181
• Product Code: LOX
• UDI-Device Identifier: 08714729783480
• UDI-Public: 08714729783480
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2022

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: 11/02/2024
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0028317296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 12/17/2021; 01/26/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 12/17/2021; 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WISPER WIRE - ABBOTT; WISPER WIRE - ABBOTT
• Patient Sex: Unknown