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

Model Number	6534
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment on guidewire occurred.The 98% stenosed target lesion was located in the mildly tortuous and moderately calcified mid right coronary artery.A 30mm x 2.25mm nc quantum apex balloon catheter was advanced for dilatation.However, when the balloon was inflated above rated burst pressure at 26 atmospheres, the balloon lumen appeared to collapse and will not pull back off the guidewire easily.The physician deflated balloon entirely, and had extreme difficulty in trying to remove it from the guidewire.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.At 113.2cm from the strain relief, the shaft and hypotube of the device was kinked.There was contrast in the inflation lumen and the balloon.There was blood in the guidewire lumen, and the balloon was loosely folded.A guidewire passed through the 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 device was wire tested with the same guidewire used to test prior.No resistance was found.The device was soaked in an uncontrolled warm temperature water bath to break up contrast and inflate the device.Upon inflation to 6atm, movement of the wire was tested, and resistance was met.The tip end of the wire had coiled segments and was met with resistance when pulled through the proximal portion of the guidewire lumen.No damage or defects were noted on the device.Product analysis did not confirm the reported event, because the guidewire passed through the device with no resistance or issues.During investigation, the wire-testing during inflation, the wire was met with resistance when attempting to advance and retract the wire.However, clinical circumstances could not be replicated.
Event or Problem Description
It was reported that catheter entrapment on guidewire occurred.The 98% stenosed target lesion was located in the mildly tortuous and moderately calcified mid right coronary artery.A 30mm x 2.25mm nc quantum apex balloon catheter was advanced for dilatation.However, when the balloon was inflated above rated burst pressure at 26 atmospheres, the balloon lumen appeared to collapse and will not pull back off the guidewire easily.The physician deflated balloon entirely, and had extreme difficulty in trying to remove it from the guidewire.The procedure was completed with another of same device.There were 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: 14577858
• Report Number: 2134265-2022-05674
• Device Sequence Number: 5078083
• Product Code: LOX
• UDI-Device Identifier: 08714729783565
• UDI-Public: 08714729783565
• 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): 07/14/2022

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: 10/20/2024
• Device Model Number: 6534
• Device Catalogue Number: 6534
• Device Lot Number: 0028242422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• 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
• Patient Sex: Unknown