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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 Obstruction of Flow (2423); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/02/2023
Event Type  malfunction  
Event Description
It was reported that the collar was partially detached.Vascular access was obtained via the radial artery.The patient presented for a complex percutaneous coronary intervention.Difficulty was encountered while attempting to deliver a stent to the target lesion and a 6f guidezilla ii guide extension catheter was requested.The device showed no defects while being flushed and prepared but was unable to cross beyond the brachial artery.The physician felt that the device gave different tactile feedback than was usual, as if the hypotube (near the hypotube transition and collar trail) was too ovoid and had something obstructing the lumen.The physician withdrew the device and tried flushing it again to see if this would help its performance, but the device could not be led down to the target vessel.The device was removed, and the procedure completed with another of the same device.Photo media provided by the customer revealed that the collar was partially detached.No patient complications were reported.
 
Manufacturer Narrative
(b)(6).
 
Manufacturer Narrative
E1 - initial reporter first name: (b)(6).The complaint device was received for product analysis.Returned product consisted of a guidezilla ii 6f guide extension catheter with blood in the device.The hypotube, shaft, collar, and tip were visually and microscopically examined.Inspection found the shaft was flattened 5-6cm and 6.5-7cm and kinked 15cm proximal of the tip.There was a kink in the hypotube 6.5cm proximal of the collar.The collar was partially detached.There were no other damage or defects observed.A 0.14 guidewire was inserted through the tip and advanced to the collar.There were some hesitations advancing through the collar due to the detachment.Seven photos provided by the site were analyzed and four of the photos depicted the partial collar detachment as observed during analysis.No other issues were identified during the product analysis.
 
Event Description
It was reported that the collar was partially detached.Vascular access was obtained via the radial artery.The patient presented for a complex percutaneous coronary intervention.Difficulty was encountered while attempting to deliver a stent to the target lesion and a 6f guidezilla ii guide extension catheter was requested.The device showed no defects while being flushed and prepared but was unable to cross beyond the brachial artery.The physician felt that the device gave different tactile feedback than was usual, as if the hypotube (near the hypotube transition and collar trail) was too ovoid and had something obstructing the lumen.The physician withdrew the device and tried flushing it again to see if this would help its performance, but the device could not be led down to the target vessel.The device was removed, and the procedure completed with another of the same device.Photo media provided by the customer revealed that the collar was partially detached.No patient complications were reported.
 
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Brand Name
GUIDEZILLA II
Type of Device
CATHETER, 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 MN 55311
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16244379
MDR Text Key308573421
Report Number2124215-2023-02896
Device Sequence Number1
Product Code DQY
UDI-Device Identifier08714729939450
UDI-Public08714729939450
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K163314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/10/2023
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 Model Number1871
Device Catalogue Number1871
Device Lot Number0029891234
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/03/2023
Initial Date FDA Received01/25/2023
Supplement Dates Manufacturer Received03/02/2023
Supplement Dates FDA Received03/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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