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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GUIDEZILLA II CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION GUIDEZILLA II CATHETER, PERCUTANEOUS Back to Search Results
Model Number 1871
Device Problems Device Damaged by Another Device (2915); Difficult to Advance (2920)
Patient Problems Death (1802); Perforation of Vessels (2135)
Event Date 12/06/2019
Event Type  Death  
Manufacturer Narrative

Date of event is an estimated date based off the aware date as the exact event date was not reported.

 
Event Description

It was reported that the guidezilla ii damaged a balloon and patient died 12 hours post procedure. The target lesion was located in a saphenous vein graft (svg). A 6f guidezilla ii was selected for use. During the procedure, the guidezilla hub was set up for femoral access. Resistance was felt when delivering the stent through the guidezilla. A balloon was advanced through the guidezilla to inflate the stent. The balloon ruptured during use. The physician speculated that the transition part of guidezilla may have contributed to a pin prick in the balloon. It was also possible that the rupture of the balloon may have been due to a calcium spike in close proximity to the transition part of guidezilla. The patient died 12 hours post procedure. The cause of death was unknown, but it may have possibly been due to heart failure due to low pressure in the left atrium.

 
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Brand NameGUIDEZILLA II
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9496851
MDR Text Key172044641
Report Number2134265-2019-15997
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK163314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1871
Device Catalogue Number1871
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 Received02/12/2020
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

Patient TREATMENT DATA
Date Received: 12/19/2019 Patient Sequence Number: 1
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