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

Model Number H7493924215050

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2017

Event Type  Malfunction  

Manufacturer Narrative

Device evaluated by mfr. : the device was returned for evaluation in two pieces. There was blood and contrast inside ad outside of the device. Microscopic and tactile inspection were done on the tip, distal shaft, collar and hypotube. Inspection noted a kink in the distal outer located 8cm from the tip and a complete separation of the shaft (at the collar) with the polytetrafluoroethylene (ptfe) completely removed from the collar. Functional testing could not be done, due to the damage on the device. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).

Event Description

Reportable based on device analysis completed on (b)(6) 2017. It was reported that the wire twisted inside the catheter and the tip damaged upon removal. A 145 guidezilla¿ guide extension catheter was selected for use. During procedure, outside patient's body, it was noted that the guidewire was twisted and the tip was damaged upon removal with no noted device separation/fracture. The procedure was completed with another of the same device. No patient complications reported and the patient's condition was stable. However, device analysis noted the collar was completely separated.

• Brand Name: GUIDEZILLA¿
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7185722
• MDR Text Key: 97088428
• Report Number: 2134265-2017-13229
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (Y/N): N
• Reporter Country Code: BR
• PMA/PMN Number: K123765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 01/12/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 11/30/2018
• Device MODEL Number: H7493924215050
• Device Catalogue Number: 39242-1505
• Device LOT Number: 19910209
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 11/08/2016
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial