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

Model Number	6533
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties occurred.The 80% stenosed target lesion was located in mildly tortuous and mildly calcified left anterior descending artery.After the non-boston scientific (bsc) wire crossed the lesion, a 20mm x 2.25mm nc quantum apex balloon catheter was advanced for dilatation.Inflation was performed three times at 28 atmospheres.However, during the removal, the balloon had difficulty pulling back off from the non-bsc guidewire despite of a lot of persistence to complete.Eventually, the device was carefully and forcefully retraced to get off the guide wire and the balloon removed fully deflated.It was noted that the balloon and shaft appear to be stretched from pulling.The procedure was completed.There were no patient complications reported.
Event or Problem Description
It was reported that removal difficulties occurred.The 80% stenosed target lesion was located in mildly tortuous and mildly calcified left anterior descending artery.After the non-boston scientific (bsc) wire crossed the lesion, a 20mm x 2.25mm nc quantum apex balloon catheter was advanced for dilatation.Inflation was performed three times at 28 atmospheres.However, during the removal, the balloon had difficulty pulling back off from the non-bsc guidewire despite of a lot of persistence to complete.Eventually, the device was carefully and forcefully retraced to get off the guide wire and the balloon removed fully deflated.It was noted that the balloon and shaft appear to be stretched from pulling.The procedure was completed.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 contrast in the inflation lumen and balloon.The balloon was loosely folded.The guidewire used in the procedure was not returned for analysis, so a test guidewire was used for functional testing.The guidewire passed through device with no resistance or issues.The guidewire was inserted through both the rapid port exchange and the tip of the device and encountered no difficulties.Product analysis did not confirm the reported events as the guidewire passed through the device with no resistance or issues.There was no damage or irregularity found to the 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15692040
• Report Number: 2124215-2022-44169
• Device Sequence Number: 12462797
• Product Code: LOX
• UDI-Device Identifier: 08714729783459
• UDI-Public: 08714729783459
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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: 07/17/2025
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0029780283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2022
• 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
• Patient Sex: Unknown