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

Model Number 1871

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 02dec2022.It was reported that the guidezilla encountered crossing difficulties.The 73% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 6f guidezilla guide extension catheter was selected for use.During procedure, it was noted that the device could not cross the lesion.The procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.However, device analysis revealed partial collar and shaft detachment.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.The device was visually and microscopically examined.There was blood present in the shaft of the device.There was partial collar and shaft detachment.At 17.8cm from the tip of the device, the shaft, markerband and tip were flattened.Angio media provided depicted no damage.Product analysis could not confirm the reported event, as the clinical circumstances could not be replicated.The flattened shaft, tip and markerband, as well as partial collar and shaft detachment found to the device during analysis could contribute to the crossing difficulty which would likely cause resistance upon entry and advancement of the device.No other issues were identified during the product analysis.

• Brand Name: GUIDEZILLA II
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16030621
• MDR Text Key: 307591202
• Report Number: 2124215-2022-54210
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K163314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2023
• Device Model Number: 1871
• Device Catalogue Number: 1871
• Device Lot Number: 0027677027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 63 KG