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

Model Number	6533
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that entrapment of device occurred.The 80% stenosed target lesion was located in mildly tortuous and mildly calcified mid left anterior descending artery.A 20mm x 2.50mm nc quantum apex was advanced for dilatation and inflated to 20 atmospheres.However, during the procedure, the device got stuck on a non-boston scientific guidewire.The balloon and guidewire were both removed from the patient's body simultaneously as one unit.It was noted that the balloon was deflated prior to removal and was removed from the patient intact.The procedure was completed with another of same device.There were no patient complications reported.
Event or Problem Description
It was reported that entrapment of device occurred.The 80% stenosed target lesion was located in mildly tortuous and mildly calcified mid left anterior descending artery.A 20mm x 2.50mm nc quantum apex was advanced for dilatation and inflated to 20 atmospheres.However, during the procedure, the device got stuck on a non-boston scientific guidewire.The balloon and guidewire were both removed from the patient's body simultaneously as one unit.It was noted that the balloon was deflated prior to removal and was removed from the patient intact.The procedure was completed with another of same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc quantum apex balloon catheter.The device was visually and microscopically examined.There was blood and contrast present in the manifold, inflation lumen and the balloon.There was blood in the guidewire lumen, and the balloon was loosely folded.At 3mm from the tip, moving proximally for a length of 12mm, there was a longitudinal tear in the balloon.The guidewire used in the procedure was not returned for analysis, so a test 0.014 guidewire was used for functional testing.The guidewire passed through device with no resistance or issues.The guidewire was inserted through both the exit notch and the tip of the device and encountered no difficulties.The guidewire passed through the device with no resistance or issues, however, clinical circumstances could not be replicated.The unreported longitudinal tear is damage that could occur during procedural use due to an interaction with patient characteristics, over inflation, or an interaction with another device.

• 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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14381192
• Report Number: 2134265-2022-04728
• Device Sequence Number: 6527755
• Product Code: LOX
• UDI-Device Identifier: 08714729783466
• UDI-Public: 08714729783466
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2022

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: 02/06/2025
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0028816437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2022
• 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: GUIDEWIRE USED: RUNTHROUGH 185CM; GUIDEWIRE USED: RUNTHROUGH 185CM
• Patient Sex: Unknown