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

Model Number 1871

Device Problems Device Damaged by Another Device (2915); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the returned product consisted of a guidezilla ii 6f guide extension catheter.The device was visually and microscopically examined.There was blood present in the collar of the device.The metal portion of the collar was damaged and pulled away from the shaft which created a hole in the shaft where the collar was pulled up.The polytetrafluoroethylene (ptfe) liner inside the shaft was pulled away from the collar indicating the device was twisted and force was applied with rotation to the device causing the damage.From the collar at 5.9-11.4cm the shaft was flattened.

Event Description

Reportable based on device analysis completed on 14oct2021.It was reported that the device was kinked.The 32mmx3.0mm, 85% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A guidezilla ii catheter-guide extension was selected for use.During the procedure, it was noted that the physician found the interface of transition segment was kinked.The device was directly removed and the procedure was completed with another of the same device.There were no complications reported and the patient is stable.However, device investigations revealed that a collar damage which created a hole or tear in the shaft.

• 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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12661613
• MDR Text Key: 277383932
• Report Number: 2134265-2021-13124
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729939450
• UDI-Public: 08714729939450
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2023
• Device Model Number: 1871
• Device Catalogue Number: 1871
• Device Lot Number: 0027076976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2021
• 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: 67 YR
• Patient Weight: 73