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

Model Number H7493924215050

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Returned product consisted of a guidezilla guide extension catheter.Microscopic and tactile inspection revealed numerous kinks in the distal shaft and hypotube.Microscopic examination revealed a partial separation at the collar/proximal shaft bond and damage to the collar.Microscopic examination found no irregularities or defects.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Reportable based on returned device analysis completed (b)(6) 2015.It was reported that the shaft of the device was kinked.During a percutaneous coronary intervention (pci), a 145, 5-in-6 guidezilla⠇uide catheter extension was selected.Upon delivering a non-bsc drug eluting stent (des), difficulty was encountered, and this device was then used.However, this device was kinked.The procedure was completed with another guidezilla.No patient complications reported and the patient's condition was good.However, returned device analysis revealed a partial shaft separation at the collar.

• 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: 5317320
• MDR Text Key: 34076784
• Report Number: 2134265-2015-09239
• 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: 12/02/2015

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: 05/31/2017
• Device Model Number: H7493924215050
• Device Catalogue Number: 39242-1505
• Device Lot Number: 18031655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2015
• 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