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

Model Number 1871

Device Problems Entrapment of Device (1212); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: used the first date of the month of the aware date as no event date was provided.

Event Description

It was reported that the stent became damaged within the guidezilla.A 3.50 x 38 synergy drug-eluting stent and a 6f guidezilla ii guide catheter were advanced for use.However, during procedure, the stent was caught on the guidezilla and the stent strut was lifted.The devices were completely removed from the patient's body and the procedure was completed with another of the same device.No patient complications nor injuries were reported.

Event Description

It was reported that the stent became damaged within the guidezilla.A 3.50 x 38 synergy drug-eluting stent and a 6f guidezilla ii guide catheter were advanced for use.However, during procedure, the stent was caught on the guidezilla and the stent strut was lifted.The devices were completely removed from the patient's body and the procedure was completed with another of the same device.No patient complications nor injuries were reported.It was further reported that the target lesion was 80-90% stenosed, located in the quite tortuous and moderately calcified mid right coronary artery.It was difficult to pass stent out of guidezilla ii catheter-guide, and it was disrupted when it was pulled back.

Manufacturer Narrative

Date of event: used the 1st day of the month of the bsc aware date as no event date was provided.

• Brand Name: GUIDEZILLA II
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9957134
• MDR Text Key: 187531386
• Report Number: 2134265-2020-05033
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729939450
• UDI-Public: 08714729939450
• Combination Product (y/n): N
• PMA/PMN Number: K163314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

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: 02/02/2021
• Device Model Number: 1871
• Device Catalogue Number: 1871
• Device Lot Number: 0023444496
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 05/14/2020
• Supplement Dates FDA Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1