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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 H7493912420350
Device Problem Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device evaluated by mfr: returned product consisted of an nc quantum apex balloon catheter in two pieces. The balloon was loosely folded. The outer shaft, inner shaft, balloon and tip were microscopically examined. The hypotube was completely separated 42. 2cm from the hub. The fracture faces were oval as if kinked prior to separation. There were numerous hypotube kinks. Inspection of the remainder of the device presented no other damage or irregularities. There was no evidence of any material or manufacturing deficiencies contributing to the damage. The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
 
Event Description
Reportable based on device analysis completed on 12-jan-2018. It was reported that shaft kink occurred. Two 20mm x 3. 50mm nc quantum apex¿ balloon catheters were advanced for dilation; however, shaft kink was noted. No patient complications were reported. 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 Key7249964
MDR Text Key99796225
Report Number2134265-2018-00427
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 01/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/20/2020
Device Model NumberH7493912420350
Device Catalogue Number39124-2035
Device Lot Number21034925
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2017
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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