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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 H74939282303010
Device Problem Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/23/2017
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older. (b)(4). Returned product consisted of a coyote nc balloon catheter. The balloon was loosely folded. The outer shaft, inner shaft, balloon and tip were microscopically examined. The hypotube shaft was completely separated 33. 2cm from the hub. The fracture faces were oval as if kinked prior to separation. There was no evidence of any material or manufacturing deficiencies contributing to the damage. There were numerous hypotube and shaft kinks. 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 analysis completed on (b)(6) 2017. It was reported that shaft kinked occurred. Vascular access was obtained utilizing cross over approach. The target lesion was located in the moderately tortuous and severely calcified below the knee vessel. A 3. 0mmx30mmx143cm fg coyote nc (nc quantum apex) balloon catheter was advanced for dilatation. However, during delivery of the device, the shaft was pushed forcibly and the shaft got kinked. The procedure was completed with another of the same device replacing the approach into ipsilateral. No patient complications were reported and the patient's status was good. However, returned device analysis revealed hypotube 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
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6901891
MDR Text Key87869133
Report Number2134265-2017-09616
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 09/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Model NumberH74939282303010
Device Catalogue Number39282-30301
Device Lot Number0019354760
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2016
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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