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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 UNK963
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/28/2018
Event Type  Malfunction  
Manufacturer Narrative

Device evaluated by mfr. : it is indicated that the device will not be returned for evaluation. If there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

 
Event Description

Same case as mdr id#: 2134265-2018-02261 and 2134265-2018-02329. It was reported that the guide extension catheter damaged another device. The target lesion was located in the circumflex artery. After engaging the lesion with a non-bsc guide catheter and a guidezilla guide extension catheter, a 4. 00x12mm synergy ii drug-eluting stent was advanced to treat the lesion. However, the device was not placed correctly and the physician then pulled the stent back through both devices. As the physician put the stent back in, the stent got stripped off the balloon at the transition, at the collar of the guidezilla. The stent was removed with the balloon together. Furthermore, a 4. 00x16mm synergy ii drug-eluting stent was advanced; however at some point during the procedure, the physician claimed that when the device was removed the balloon looked larger on either side of the stent. Thus, the physician opted not to use the device. The procedure was completed with another synergy stent. No patient complications were reported and the patient's status was fine.

 
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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 Key7376875
MDR Text Key103801296
Report Number2134265-2018-03092
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
Type of Report Initial
Report Date 02/28/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/28/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNK963
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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