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	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The shaft, collar, and tip were microscopically and visually examined.Blood was present inside the shaft.Inspection of the device revealed that there was a shaft separation at the collar.There was damage to the end of the shaft separation.The polytetrafluoroethylene (ptfe) was pulled out of the collar and attached to the distal shaft.There were numerous slight bents in the proximal end of the shaft.There were only slight bends present no shaft kinks during analysis; however, it was most likely that the shaft got severely kinked at the collar, separating the shaft from the collar.The photo was reviewed for analysis.The photo showed that the shaft was separated at the collar and with slight bends at the proximal end.
Event or Problem Description
Reportable based on device analysis completed on 22sep2021.It was reported that the device was kinked.The target lesion was located in the left anterior descending artery.A 5-in-6 guidezilla guide extension catheter was selected for use.During the procedure, it was noted that the joint segment of the catheter was kinked thus, could not be used.The catheter was then replaced with another of the same to complete the procedure.There were no complications reported and patient was stable post procedure.However, device analysis revealed a shaft separation.

• Brand Name: GUIDEZILLA
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12624358
• Report Number: 2134265-2021-12806
• Device Sequence Number: 16494382
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2021

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: 05/21/2022
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0025529985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 62