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

Model Number	1867
Medical Device Problem Codes	Entrapment of Device (1212); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a guidezilla was stuck in the lesion.The target lesion was located in the left circumflex artery.A guidezilla guide extension catheter was selected for use.During the procedure, it was noted that the device was scratched and stuck in the lesion.The device was removed normally with the ancillary device.The procedure was completed with another of same device.No intervention was done and no patient complications were reported.
Event or Problem Description
It was reported that a guidezilla was stuck in the lesion.The target lesion was located in the left circumflex artery.A guidezilla guide extension catheter was selected for use.During the procedure, it was noted that the device was scratched and stuck in the lesion.The device was removed normally with the ancillary device.The procedure was completed with another of same device.No intervention was done and no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was visually and microscopically examined.There was blood present in the shaft of the device.There were numerous shaft kinks.For a length of 1.1cm from the tip of the device, the shaft, marker band, and tip of the device was flattened.Within the length of the flat shaft, there was drag.Product analysis for the reported event of the device being stuck in the lesion could not be performed as the clinical circumstances could not be replicated.However, the shaft kinks, flattened shaft, marker band, and tip found to the device during analysis supports the reported event as such which would indicate device resistance and procedural difficulties.

• 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: 13157049
• Report Number: 2134265-2021-16311
• Device Sequence Number: 4147318
• 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
• Report Date (Section B): 02/14/2022

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: 10/29/2022
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0026273011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/24/2021
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2020
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 73 KG