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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493912415400
Device Problem Device Difficult to Setup or Prepare (1487)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device evaluated by mfr. : returned product consisted of a nc quantum apex balloon catheter in two pieces. The balloon was loosely folded and there was blood in the lumen. The balloon, markerbands, proximal weld, and shaft were microscopically inspected. Inspection revealed numerous kinks in the hypotube, with the device separating at the distal edge of the port/exit notch. The separation is consistent with excessive tensile force. The port/exit notch was also revealed to have damage (stretched and perforation). Functional testing could not be done, due to the condition of the returned device. Microscopic inspection found the remainder of the device free of damage. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).
 
Event Description
Reportable based on device analysis completed on 22-aug-2016. It was reported that prepping difficulties were encountered. A 15mmx4. 00mm nc quantum apex¿ balloon catheter was advanced for dilatation; however the catheter kept pulling air while it was inside the patient. The catheter was re-primed; however the air was stuck inside the catheter tubing. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was fine. However, returned device analysis revealed shaft break.
 
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Brand NameNC QUANTUM APEX¿
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5960642
MDR Text Key55098765
Report Number2134265-2016-08135
Device Sequence Number1
Product Code LOX
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Model NumberH7493912415400
Device Catalogue Number39124-1540
Device Lot Number19231921
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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