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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 6534
Device Problem Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2022
Event Type  malfunction  
Event 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.
 
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 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.
 
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Brand Name
NC QUANTUM APEX
Type of Device
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 Key14577858
MDR Text Key293274434
Report Number2134265-2022-05674
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729783565
UDI-Public08714729783565
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number6534
Device Catalogue Number6534
Device Lot Number0028242422
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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