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

Model Number H7493933515060

Device Problems Difficult to Remove (1528); Device Damaged by Another Device (2915); Tip (3123)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2018

Event Type  Malfunction  

Manufacturer Narrative

(b)(4). Device evaluated by mfr: the guidezilla device was returned bloody. The hypotube, collar, distal shaft and tip were microscopically and tactile inspected. Inspection revealed numerus kinks in the distal shaft, a kink in the hypotube located 2 mm from the collar, tip damage (misshapen/inverted/abrasions), and shaft damage (braid broken/outer shaft material separated) located 6. 5 cm from the collar. The shaft damage appears to have been caught on something and then torn, leaving the ptfe liner intact. 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) 2018. It was reported that there was difficulty removing the stent through the catheter and the tip became damaged. A 6f guidezilla¿ ii guide extension catheter was selected for a percutaneous coronary intervention, in the severely tortuous, moderately calcified, and 90% stenosed right coronary artery (rca) , for a patient with a leiomyoma. An attempt was made to stent with an non-bsc stent, but it failed to cross the rca. When attempting to remove the stent, the stent's strut became deformed and the tip was damaged when it was tugged at the guidezilla tip. The guidezilla tip was also deformed. No additional interventions were performed. The procedure completed with a new guidezilla ii device and the synergy stent successfully. No patient complications were reported. The patients condition after the procedure was good. However, device analysis revealed material separation at the shaft.

• Brand Name: GUIDEZILLA¿ II GUIDE EXTENSION CATHETER
• 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: 7362841
• MDR Text Key: 103413151
• Report Number: 2134265-2018-01978
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (Y/N): N
• Reporter Country Code: KR
• PMA/PMN Number: K163314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/26/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 03/22/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 05/22/2019
• Device MODEL Number: H7493933515060
• Device LOT Number: 20802030
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 06/23/2017
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial