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

Model Number	1867
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidezilla was fractured.A 5-in-6 guidezilla guide extension catheter was selected for use in the left anterior descending artery.During preparation, it was noted that the hypotube transition section was fractured when the physician was about to take out the guidezilla.The procedure was completed with another of the same device.No complications were reported, and the patient was in good postoperative condition.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The device was visually and microscopically examined.Distal to the collar, there was partial detachment of the shaft.There was no further damage or irregularities.There were no fluids present to the device.Photo media depicted outer box packaging to the reported complaint device; however, the media provided cannot confirm the reported event.Product analysis confirmed the reported event, as the shaft was partially detached just distal from the collar.The damage to the device indicates there was force during to handling of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the guidezilla was fractured.A 5-in-6 guidezilla guide extension catheter was selected for use in the left anterior descending artery.During preparation, it was noted that the hypotube transition section was fractured when the physician was about to take out the guidezilla.The procedure was completed with another of the same device.No complications were reported, and the patient was in good postoperative condition.

• Brand Name: GUIDEZILLA
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16414542
• Report Number: 2124215-2023-08067
• Device Sequence Number: 5742708
• Product Code: DQY
• UDI-Device Identifier: 08714729839859
• UDI-Public: 08714729839859
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 04/21/2023

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: 12/18/2022
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0026544452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2020
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 66 KG