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

Model Number	1867
Medical Device Problem Codes	Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Analysis of the collar and hypotube included microscopic and visual inspection.Inspection revealed a complete separation at the collar/shaft area with part of the shaft still attached to the collar.Inspection found no other damage or defect with the device.
Event or Problem Description
Reportable based on device analysis completed on 18feb2021.It was reported that the tip of the guidezilla was kinked.The target lesion was located in the left coronary artery.A 5-in-6 guidezilla catheter guide extension was selected for use.During procedure, it was noted that the tip of the device was kinked and could not be advanced.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.However, device analysis revealed that a complete separation at the collar/shaft area occurred with part of the shaft still attached to the collar.

• Brand Name: GUIDEZILLA
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11399578
• Report Number: 2134265-2021-02569
• Device Sequence Number: 19678489
• 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): 03/02/2021

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: 02/25/2021
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0023402575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 62