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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 Difficult to Insert (1316); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/17/2023
Event Type  malfunction  
Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).
 
Event Description
It was reported that a device separation occurred.A 6f guidezilla ii was selected for use.During the procedure, the guidezilla was unable to fully insert inside sheath.Upon pulling out, plastic part of extension catheter separated from the wire.It was unknown if how the procedure was completed.There were no patient complications reported post procedure.
 
Event Description
It was reported that a device separation occurred.A 6f guidezilla ii was selected for use.During the procedure, the guidezilla was unable to fully insert inside sheath.Upon pulling out, plastic part of extension catheter separated from the wire.It was unknown if how the procedure was completed.There were no patient complications reported post procedure.
 
Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).The device was returned and evaluated by manufacturer: visual inspection revealed that the collar weld plate was separated and for a length of 8mm running proximal from the tip, the shaft and tip were flattened.Microscopic inspection revealed no further damage or irregularity.There was blood present in the shaft of the device.
 
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Brand Name
GUIDEZILLA II
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18608769
MDR Text Key334664543
Report Number2124215-2024-03232
Device Sequence Number1
Product Code DQY
UDI-Device Identifier08714729939450
UDI-Public08714729939450
Combination Product (y/n)N
Reporter Country CodeRP
PMA/PMN Number
K163314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 01/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2024
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 Number0031759289
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/06/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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