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

Model Number H7493924215050

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the shaft was fractured.The target lesion was located in the right circumflex artery.A guidezilla¿ guide extension catheter was selected for use.During the procedure, it was noted that the connection part of the guide extension catheter was fractured.The procedure was completed with another of same device.No complications were reported and the patient's condition was stable.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.Returned product consisted of a guidezilla guide extension catheter in two pieces.The tip, distal shaft, collar and hypotube was microscopically and tactile inspected.Inspection revealed a complete separation at the collar, a kink in the distal shaft located 3cm from the tip, and the tip was damaged (flattened) at the markerband.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

It was reported that the shaft was fractured.The target lesion was located in the right circumflex artery.A guidezilla guide extension catheter was selected for use.During the procedure, it was noted that the connection part of the guide extension catheter was fractured.The procedure was completed with another of same device.No complications were reported and the patient's condition was stable.

• Brand Name: GUIDEZILLA¿
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7769507
• MDR Text Key: 116709116
• Report Number: 2134265-2018-07079
• 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
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2019
• Device Model Number: H7493924215050
• Device Catalogue Number: 39242-1505
• Device Lot Number: 0021477691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Date Manufacturer Received: 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1