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	12/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 26jan2022.It was reported that the catheter became kinked.A guidezilla guide extension catheter was selected for use in the left anterior descending artery.After the physician opened the package, it was found that the connection of the delivery shaft and the access 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 collar and shaft partial detachment.
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.There was blood present in the shaft of the device as well as on the tip.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 were damaged and slightly twisted.The jagged edge of the detached shaft indicated that the device was likely kinked and rotated with force during handling of the device.The shaft and collar partial detachment was likely caused from a shaft kink as the ptfe and attached portion of the shaft showed signs of a kink.The shaft underneath the collar also showed signs of a kink as it was no longer connected with the collar.The damage to the device indicated there was force during 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: 13551195
• Report Number: 2134265-2022-01639
• Device Sequence Number: 20089600
• 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): 02/17/2022

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: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/17/2022
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 86 KG