MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GUIDEZILLA; CATHETER, PERCUTANEOUS

Model Number	1867
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).
Event or Problem Description
It was reported that the shaft break occurred.A guidezilla guide extension catheter was selected for use.Upon unpacking, the catheter was found to be broken at the front end of the catheter.The outer packing and carrier tube was intact.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.
Event or Problem Description
It was reported that the shaft break occurred.A guidezilla guide extension catheter was selected for use.Upon unpacking, the catheter was found to be broken at the front end of the catheter.The outer packing and carrier tube was intact.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was not returned for analysis.However, an analysis was concluded based on the provided photo of the complaint device and it was observed a shaft break consequently, confirming the reported complaint.
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The device was visually and microscopically examined.At 24.6cm from the tip of the device, the shaft was detached at the collar and polytetrafluoroethylene (ptfe) was peeled our and still connected within the collar to the detached portion of the device.The ends of the detached shaft are damaged and slightly twisted.The damage to the ptfe and the jagged edges of the detached shaft indicates that the device was rotated with force during handling of the device.There was no presence of blood within the device however, there were traces of blood present on the outside of the shaft.
Event or Problem Description
It was reported that the shaft break occurred.A guidezilla guide extension catheter was selected for use.Upon unpacking, the catheter was found to be broken at the front end of the catheter.The outer packing and carrier tube was intact.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.

• Brand Name: GUIDEZILLA
• Common Device Name: 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12495466
• Report Number: 2134265-2021-11696
• Device Sequence Number: 17120579
• Product Code: DQY
• UDI-Device Identifier: 08714729839859
• UDI-Public: 08714729839859
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2022
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0025819825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 09/23/2021; 11/19/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 10/13/2021; 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male