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

Model Number 1873

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2019

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 stent damage occurred.A 4.50 x 24 synergy drug-eluting stent and a 6f guidezilla ii guide extension catheter were selected for use.During procedure, it was noted that the stent clung to the junction zone of the guidezilla and the stent struts came out.The procedure time was lengthened but no clinical consequence were observed.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The hypotube, collar, distal shaft and tip was microscopically and visually inspected.Visual inspection revealed multiple minor flat spots along the distal shaft.Microscopic inspection revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that stent damage occurred.A 4.50 x 24 synergy drug-eluting stent and a 6f guidezilla ii guide extension catheter were selected for use.During procedure, it was noted that the stent clung to the junction zone of the guidezilla and the stent struts came out.The procedure time was lengthened but no clinical consequence were observed.

• 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: 8763981
• MDR Text Key: 150134613
• Report Number: 2134265-2019-07828
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729939467
• UDI-Public: 08714729939467
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2020
• Device Model Number: 1873
• Device Catalogue Number: 1873
• Device Lot Number: 0022504296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2019
• Date Manufacturer Received: 07/12/2019
• Patient Sequence Number: 1