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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GUIDEZILLA; CATHETER, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION GUIDEZILLA; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 1867
Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/22/2020
Event Type  malfunction  
Event Description
It was reported that the collar of the guidezilla got detached.The 85% stenosed target lesion area was located in the severely tortuous and severely calcified middle and distal left anterior descending artery.A 4.00 x 38mm promus element plus drug-eluting stent and a 145 5 in 5 guidezilla guide extension catheter were selected for a percutaneous coronary intervention.After balloon pre-dilatation, the guidezilla and promus were advanced.However, it was noted that the stent got stuck with in the guide extension catheter.The collar of the guidezilla guide extension catheter got detached after retraction and it was found that the stent struts were lifted.The devices were removed completely from the patient's body.The procedure was completed with another of the same device.No complications were reported and the patient status was stable.
 
Manufacturer Narrative
Device evaluated by manufacturer.The device was returned for analysis.Returned product consisted of a guidezilla guide extension guide catheter with the distal shaft detached from the collar.The device was bloody and only 12.5 cm of the distal shaft was returned for analysis.Analysis of the tip, distal shaft, collar, and hypotube included microscopic and visual inspection.Inspection revealed a complete separation of the distal shaft at the collar, numerous kinks in the distal shaft, numerous kinks in the hypotube, tip damage (tip partially missing), collar damage, and distal shaft damage (mechanical separation, flattened).Inspection of the rest of the device found no other damage or defects with the returned device.The undamaged and damaged portion of the outer diameter (od) of the distal shaft were measured with a calibrated micrometer.The undamaged outer diameter measured.066 meeting the specification of.067 and the damaged od measured.091 exceeding the specification.067.The damage to the returned device was excessive and functional/device-to-device testing was not possible.The device jamming could not be confirmed due to the condition of the returned device.
 
Event Description
It was reported that the collar of the guidezilla got detached.The 85% stenosed target lesion was located in the severely tortuous and severely calcified middle and distal left anterior descending artery.Following pre-dilatation, the physician advanced a guidezilla guide extension catheter.Subsequently.A 4.00x38mm promus element plus drug-eluting stent was advanced for treatment but it got stuck in the guide extension catheter.The collar of the guidezilla guide extension catheter got detached after retraction, and it was found that the stent struts were lifted.The device was simply pulled out completely from the patient's body and the procedure was completed with a different device.There were no patient complications reported and the patient is stable.
 
Manufacturer Narrative
Device evaluated by manufacturer.The device was returned for analysis.Returned product consisted of a guidezilla guide extension guide catheter with the distal shaft detached from the collar.The device was bloody and only 12.5 cm of the distal shaft was returned for analysis.Analysis of the tip, distal shaft, collar, and hypotube included microscopic and visual inspection.Inspection revealed a complete separation of the distal shaft at the collar, numerous kinks in the distal shaft, numerous kinks in the hypotube, tip damage (tip partially missing), collar damage, and distal shaft damage (mechanical separation, flattened).Inspection of the rest of the device found no other damage or defects with the returned device.The undamaged and damaged portion of the outer diameter (od) of the distal shaft were measured with a calibrated micrometer.The undamaged outer diameter measured.066 meeting the specification of.067 and the damaged od measured.091 exceeding the specification.067.The damage to the returned device was excessive and functional/device-to-device testing was not possible.The device jamming could not be confirmed due to the condition of the returned device.
 
Event Description
It was reported that the collar of the guidezilla got detached.The 85% stenosed target lesion area was located in the severely tortuous and severely calcified middle and distal left anterior descending artery.A 4.00x38mm promus element plus drug-eluting stent and a 145 5 in 5 guidezilla guide extension catheter were selected for a percutaneous coronary intervention.After balloon pre-dilatation, the guidezilla and promus were advanced.However, it was noted that the stent got stuck with in the guide extension catheter.The collar of the guidezilla guide extension catheter got detached after retraction and it was found that the stent struts were lifted.The devices were removed completely from the patient's body.The procedure was completed with another of the same device.No complications were reported and the patient status was stable.It was further reported that resistance was met in the guidezilla and then the device was removed.
 
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Brand Name
GUIDEZILLA
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10373166
MDR Text Key201861762
Report Number2134265-2020-10517
Device Sequence Number1
Product Code DQY
UDI-Device Identifier08714729839859
UDI-Public08714729839859
Combination Product (y/n)N
PMA/PMN Number
K123765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 09/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/04/2021
Device Model Number1867
Device Catalogue Number1867
Device Lot Number0024548911
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2020
Initial Date Manufacturer Received 07/23/2020
Initial Date FDA Received08/06/2020
Supplement Dates Manufacturer Received08/24/2020
08/28/2020
Supplement Dates FDA Received08/31/2020
09/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age71 YR
Patient Weight61
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