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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 H7493912420300
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/08/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that shaft break occurred. A 20mm x 3. 00mm nc quantum apex¿ balloon catheter was advanced through the guide catheter to dilate the lesion. However, the device was stuck to the guide catheter and blood came out of the proximal end. The device was eventually removed, however it was noted that the 60cm of the distal tip and the balloon of the device were still in the guide catheter. Another balloon was then advanced and fixed the remaining half of the nc quantum apex¿ balloon catheter to the wall of the guide catheter. Both of the balloon catheter and guide catheter were slowly pulled out and were completely removed from the patient. The procedure was completed with another of the same device. No patient complications were reported and no harm to the patient.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a nc quantum apex balloon catheter. The balloon was tightly folded. There was contrast in the inflation lumen. There was blood in between balloon folds. The outer shaft, inner shaft, balloon and tip were microscopically examined. The hypotube shaft was completely separated 62cm from the hub. The fracture faces were oval as if kinked prior to separation. There were numerous hypotube kinks. There was tip damage. There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty. 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
It was reported that shaft break occurred. A 20mm x 3. 00mm nc quantum apex¿ balloon catheter was advanced through the guide catheter to dilate the lesion. However, the device was stuck to the guide catheter and blood came out of the proximal end. The device was eventually removed, however it was noted that the 60cm of the distal tip and the balloon of the device were still in the guide catheter. Another balloon was then advanced and fixed the remaining half of the nc quantum apex¿ balloon catheter to the wall of the guide catheter. Both of the balloon catheter and guide catheter were slowly pulled out and were completely removed from the patient. The procedure was completed with another of the same device. No patient complications were reported and no harm to the patient.
 
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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
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6185194
MDR Text Key62707331
Report Number2134265-2016-12036
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
K121667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model NumberH7493912420300
Device Catalogue Number39124-2030
Device Lot Number0019820188
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/19/2016 Patient Sequence Number: 1
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