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

Model Number	H7493933515070
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter broke.The patient presented with chronic total occlusion (cto).The patient's subclavian appeared to be tortuous and the takeoff of the saphenous vein graft (svg) was difficult to engage.The guidezilla guide extension catheter was used to help with engagement in the moderately tortuous and non-calcified svg retrograde to the cto radially.During the procedure, there was difficulty getting a trapper balloon through the guidezilla to trap out a microcatheter.While trying to get the equipment out, the trapper was stuck.The guidezilla broke near the transition collar and the trapper shaft also broke.The balloon was successfully removed and after several techniques were used, the guidezilla was also able to be removed.There was difficulty with the rest of the procedure, so the cto was never completed.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The device was visually and microscopically examined.There was blood present in the shaft of the device.The collar and shaft were fully separated with the polytetrafluoroethylene (ptfe) liner pulled from the collar.No other damages or irregularities were found to the device.Media provided by the site depicts a fully separated shaft and collar with polytetrafluoroethylene (ptfe) visible on the shaft end of the separation.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the catheter broke.The patient presented with chronic total occlusion (cto).The patient's subclavian appeared to be tortuous and the takeoff of the saphenous vein graft (svg) was difficult to engage.The guidezilla guide extension catheter was used to help with engagement in the moderately tortuous and non-calcified svg retrograde to the cto radially.During the procedure, there was difficulty getting a trapper balloon through the guidezilla to trap out a microcatheter.While trying to get the equipment out, the trapper was stuck.The guidezilla broke near the transition collar and the trapper shaft also broke.The balloon was successfully removed and after several techniques were used, the guidezilla was also able to be removed.There was difficulty with the rest of the procedure, so the cto was never completed.No patient complications were reported.
Event or Problem Description
It was reported that the catheter broke.The patient presented with chronic total occlusion (cto).The patient's subclavian appeared to be tortuous and the takeoff of the saphenous vein graft (svg) was difficult to engage.The guidezilla guide extension catheter was used to help with engagement in the moderately tortuous and non-calcified svg retrograde to the cto radially.During the procedure, there was difficulty getting a trapper balloon through the guidezilla to trap out a microcatheter.While trying to get the equipment out, the trapper was stuck.The guidezilla broke near the transition collar and the trapper shaft also broke.The balloon was successfully removed and after several techniques were used, the guidezilla was also able to be removed.There was difficulty with the rest of the procedure, so the cto was never completed.No patient complications were reported.
Additional Manufacturer Narrative
This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.Device evaluated by mfr: the device was returned for evaluation.The device was visually and microscopically examined.There was blood present in the shaft of the device.The collar and shaft were fully separated with the polytetrafluoroethylene (ptfe) liner pulled from the collar.No other damages or irregularities were found to the device.Media provided by the site depicts a fully separated shaft and collar with polytetrafluoroethylene (ptfe) visible on the shaft end of the separation.No other issues were identified during the product analysis.

• Brand Name: GUIDEZILLA II
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18000521
• Report Number: 2124215-2023-56803
• Device Sequence Number: 7696464
• Product Code: DQY
• UDI-Device Identifier: 08714729939474
• UDI-Public: (01)08714729939474(17)250612(10)31807099
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K163314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2024

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: 06/12/2025
• Device Model Number: H7493933515070
• Device Catalogue Number: H7493933515070
• Device Lot Number: 0031807099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 11/15/2023; 06/12/2024
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 11/21/2023; 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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 Sex: Unknown