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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE GUIDEZILLA¿ CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE GUIDEZILLA¿ CATHETER, PERCUTANEOUS Back to Search Results
Model Number H7493924215050
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/09/2017
Event Type  Malfunction  
Manufacturer Narrative

Device evaluated by mfr. : the device was returned for evaluation in two pieces. There was blood and contrast inside ad outside of the device. Microscopic and tactile inspection were done on the tip, distal shaft, collar and hypotube. Inspection noted a kink in the distal outer located 8cm from the tip and a complete separation of the shaft (at the collar) with the polytetrafluoroethylene (ptfe) completely removed from the collar. Functional testing could not be done, due to the damage on the device. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. 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 (b)(6) 2017. It was reported that the wire twisted inside the catheter and the tip damaged upon removal. A 145 guidezilla¿ guide extension catheter was selected for use. During procedure, outside patient's body, it was noted that the guidewire was twisted and the tip was damaged upon removal with no noted device separation/fracture. The procedure was completed with another of the same device. No patient complications reported and the patient's condition was stable. However, device analysis noted the collar was completely separated.

 
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Brand NameGUIDEZILLA¿
Type of DeviceCATHETER, 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 Key7185722
MDR Text Key97088428
Report Number2134265-2017-13229
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeBR
PMA/PMN NumberK123765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 12/20/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/12/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2018
Device MODEL NumberH7493924215050
Device Catalogue Number39242-1505
Device LOT Number19910209
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/06/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/08/2016
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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