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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 6531
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/29/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 60% stenosed target lesion was located in the mildly tortuous left anterior descending artery.A 12mm x 2.75mm nc quantum apex balloon catheter was advanced for use.However, during procedure, the proximal shaft of stainless steel hypotube was broke in half inside guiding catheter and the broke was approximately 30cm from the hub.The device was completely removed and another nc balloon catheter was used to complete the procedure.There were no patient complications reported.
 
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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
MDR Report Key10187143
Report Number2134265-2020-07479
Device Sequence Number886214
Product Code LOX
UDI-Device Identifier08714729783251
UDI-Public08714729783251
Combination Product (Y/N)N
Initial Reporter StateHI
Initial Reporter CountryUS
PMA/510(K) Number
K121667
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/23/2020
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 Date10/09/2022
Device Model Number6531
Device Catalogue Number6531
Device Lot Number0024573662
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/30/2020
Initial Report FDA Received Date06/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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