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

Model Number	1867
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 22dec2021.It was reported that the connection between the delivery shaft and guiding catheter was kinked.A guidezilla guide extension catheter was selected for use on the stenosed and tortuous right coronary artery.During preparation, the physician unpacked the device and found the connection part between the delivery shaft and guiding catheter was kinked.The procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.However, device analysis revealed that the collar was partially detached, and the shaft was partially detached and torn.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.Returned product consisted of the guidezilla i45 guide extension catheter.The device was visually and microscopically examined.The collar was partially detached.At the most distal end of the collar, the shaft was partially detached and torn.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 likely kinked and 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.The shaft and collar were partially detached likely caused from a shaft kink as the ptfe and attached portion of the shaft show signs of a kink.The damage to the device indicates there was force during to handling of the device.

• 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: 13255758
• Report Number: 2134265-2021-16740
• Device Sequence Number: 17291734
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2022

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: 09/23/2022
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0026069368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2020
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 80 KG