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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE GUIDEZILLA¿ II GUIDE EXTENSION CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number H7493933515060
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

Same case as mdr id 2134265-2018-05482. It was reported that the shaft of the synergy broke upon removal from the guidezilla. The target lesion was extremely tortuous. A 6f guidezilla¿ ii guide extension catheter and 4. 00 x 24 synergy ii drug-eluting stent were selected for the percutaneous coronary intervention (pci) procedure. After deploying the stent, and upon removal of the stent delivery system (sds) through the distal portion of the guidezilla, the shaft of the sds broke. Due to having an unspecified buddy wire in the guidezilla , there was very little head room. Also while trying to pull the sds out, drag was encountered due to the extremely tortuous vessel. The procedure was completed successfully. No patient complications reported.

 
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Brand NameGUIDEZILLA¿ II GUIDE EXTENSION CATHETER
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 Key7627106
MDR Text Key112053836
Report Number2134265-2018-05466
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK163314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/29/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/21/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/11/2020
Device MODEL NumberH7493933515060
Device LOT Number0021982646
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/13/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/03/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/12/2018
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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