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

Model Number 1873

Device Problems Device Damaged by Another Device (2915); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 year or older.Device evaluated by manufacturer: the device was returned for analysis.The distal shaft was clotted with blood.Blood was removed during the lab analysis.The tip, distal shaft, collar and hypotube were microscopically and visually inspected.Inspection revealed a kink in the hypotube located 6.1 cm from the strain relief, collar damage (apex of collar flared upwards), and tip damage (torn/misshapen).Inspection of the rest of the device found no other damage or irregularities.Functional testing was performed with a test stented balloon catheter.The stented device was loaded into the guidezilla collar, and advanced through the tip without issue.The collar of the device was measured was within specification.The tip could not be accurately measured due to the tip damage.

Event Description

Reportable based on device analysis completed on (b)(6) 2019.It was reported that the stent dislodged inside the catheter.The target lesion was located in the moderately tortuous proximal left anterior descending artery.A guidezilla ii guide extension catheter was selected for use.During procedure, an unknown stent was unable to cross the lesion, thus it was deilvered in combination with the guidezilla catheter.The stent was tried to advance as it was into the patient's body even if there was resistance felt at the port part of the catheter.Subsequently,it was noted that the stent dislodged inside the collar part of the catheter under fluoroscopy.The dislodged stent was then removed together with the catheter.The procedure was completed with this device.No patient complications were reported.However, analysis revealed that the apex of the collar flared upwards.

• 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: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8599444
• MDR Text Key: 144710162
• Report Number: 2134265-2019-05080
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729939467
• UDI-Public: 08714729939467
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K163314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2020
• Device Model Number: 1873
• Device Catalogue Number: 1873
• Device Lot Number: 0022824713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 05/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2018
• 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
• Treatment: STENT- ULTIMASTER