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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.
 
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.
 
Manufacturer Narrative
Updated: device evaluated by mfr. , eval summary attached, method codes, result codes, and conclusion codes. Device evaluated by mfr: the device was returned for analysis. Returned product consisted of a 6f guidezilla 2 guide extension catheter with two unidentified guide wire and the distal end of the related synergy stented balloon catheter were all inside the guidezilla distal shaft. The hypotube, collar, distal shaft and tip was microscopically and tactile inspected. Inspection revealed tip damage (flattened/abrasions/notched/ misshapen), distal shaft damage (abrasions), and collar damage (distal shaft material was pushed inward). The collar inner diameter (id) was measured using a calibrated pin gage, and the collar was found to be measuring. 057¿ and met specification. The tip of the device could not be pinned due to the excessive damage. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. Functional testing was conducted with a lab supplied, test 4. 0 mm stented catheter. The test device was loaded into the collar and advanced easily until approximately 4 mm from the tip. Additional force was applied, and the test device did exit out from the tip of the guidezilla. The test device was then withdrawn with extra manipulation/force. 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).
 
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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
MDR Report Key7627106
MDR Text Key112053836
Report Number2134265-2018-05466
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K163314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
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
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/03/2018
Is This a Reprocessed and Reused Single-Use Device? No

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