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

Model Number	6534
Medical Device Problem Code	Difficult to Remove (1528)
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 were encountered.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.A 30mm x 2.75mm nc quantum apex balloon catheter was advanced for dilation.The balloon was inflated twice at 28 atmospheres.However, the balloon was very difficult to remove from a non-bsc guidewire although it was in fully deflated state.Eventually, the device was able to be pulled off the guidewire.The procedure was completed successfully with no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc quantum apex balloon catheter with a non-bsc guidewire.The device was visually and microscopically examined.There was contrast in the inflation lumen and balloon.The balloon was loosely folded.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.A laser micrometer was used to measure the outer diameter of the non-bsc guidewire returned within the balloon catheter.The exposed and undamaged portion of the wire was of compatible use with the balloon.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.
Event or Problem Description
It was reported that removal difficulties were encountered.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.A 30mm x 2.75mm nc quantum apex balloon catheter was advanced for dilation.The balloon was inflated twice at 28 atmospheres.However, the balloon was very difficult to remove from a non-bsc guidewire although it was in fully deflated state.Eventually, the device was able to be pulled off the guidewire.The procedure was completed successfully with no patient complications reported.

• 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: 15691726
• Report Number: 2124215-2022-44060
• Device Sequence Number: 15159082
• Product Code: LOX
• UDI-Device Identifier: 08714729783589
• UDI-Public: 08714729783589
• 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): 12/05/2022

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: 09/14/2024
• Device Model Number: 6534
• Device Catalogue Number: 6534
• Device Lot Number: 0028022467
• 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: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• 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: GUIDEWIRE - RUNTHROUGH BRAND WIRE; GUIDEWIRE - RUNTHROUGH BRAND WIRE
• Patient Sex: Unknown