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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
Device Problems Device Damaged by Another Device (2915); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/18/2020
Event Type  Malfunction  
Event Description

It was reported that stent was damage upon removal. The target lesion was in the severely tortuous and calcified proximal, mid and distal right coronary artery. A 4. 00x28 and 4. 00x16 synergy drug eluting stent were used for teatment together with the guidezilla guide extension catheter. During procedure, two synergy stents were deployed in the vessel and a non-bsc stent were used distal to the two synergy. Subsequently, the 4. 00x28 stent was placed into the vessel but could not advance to the distal lesion and got unraveled when removed from the patient's body. Then, a 4. 0x16 stent was advanced in the guidezilla however it could not pass the transition part. The stent delivery system was able to be removed but the stent was stuck in the shaft of the co-pilot tuohy. The procedure was completed with a different device. No complications reported and there was no harm on the patient.

 
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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
two scimed place
maple grove
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10129972
MDR Text Key194388952
Report Number2134265-2020-07552
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/08/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received06/23/2020
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: 06/08/2020 Patient Sequence Number: 1
Treatment
STENT BALLOON EXPANDABLE-4.0X16 SYNERGY; STENT BALLOON EXPANDABLE-4.0X28 SYNERGY
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