MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE GUIDEZILLA¿; CATHETER, PERCUTANEOUS

Model Number H7493924215050

Device Problems Failure to Deliver (2338); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Microscopic and tactile inspection revealed a kink in the hypotube 27cm from the strain relief.Microscopic examination revealed a partial separation at the collar/proximal location.A.057¿ tooling qualified was inserted through the collar with no resistance.Microscopic and tactile examination found no irregularities or defects.The inner diameter (id) of the guidezilla was measured at the distal tip using a calibrated pin gauge set and was within specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.(b)(4).

Event Description

Reportable based on device analysis completed on 02june2016.It was reported that the catheter failed to deliver the stent.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified mid right coronary artery (rca).A 145 guidezilla¿ was used to deliver a 3.0/18 non-bsc stent but failed to deliver it further at proximal rca due to severe resistance.When the device was removed from the patient, it was noted that the proximal part of the stent was lifted.The procedure was completed with a different device.No patient complications were reported and the patient's condition was good.However, device analysis revealed a partial separation at the collar/proximal location.

• Brand Name: GUIDEZILLA¿
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5755720
• MDR Text Key: 48356209
• Report Number: 2134265-2016-05521
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K123765
• 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: 06/02/2016

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: 11/30/2017
• Device Model Number: H7493924215050
• Device Catalogue Number: 39242-1505
• Device Lot Number: 18630202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2016
• Initial Date FDA Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2015
• 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