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

Model Number	1867
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Analysis of the tip, distal shaft, collar and hypotube included microscopic and visual inspection.Inspection revealed a partial separation at the shaft/collar area, and there was numerous hypotube kinks.Inspection of the rest of the device found no other damage or defect.
Event or Problem Description
Reportable based on device analysis completed on 26feb2021.It was reported that the guidezilla could not cross the lesion.The 70% stenosed target lesion was located in the tortuous and mildly calcified anterior descending artery.A 5-in-6 guidezilla guide extension catheter was selected for use.During procedure, it was noted that the device could not cross the lesion due to vessel tortuosity and mild calcification.The procedure was completed with another of same device.No patient complications were reported and the patient was stable post procedure.However, device analysis revealed that there was a partial separation at the shaft/collar area.

• Brand Name: GUIDEZILLA
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11485770
• Report Number: 2134265-2021-03274
• Device Sequence Number: 19686339
• 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): 03/15/2021

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: 0025821645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1