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 01/27/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of a guidezilla guide extension catheter with a non-bsc stented balloon catheter (4.0mm x 34mm).There were numerous kinks throughout the hypotube of the non-bsc device, with stent damage and tip damage.There was blood inside and outside of the guidezilla distal shaft.The hypotube, collar, distal shaft and tip were microscopically and tactile inspected.Inspection revealed a partial separation at the collar and a kink in the distal shaft, located 35mm from the tip.The inner diameter (id) of the guidezilla was measured at the distal tip and was within specification.A.057¿ tooling qualified mandrel was inserted through the collar with no resistance.Functional testing was attempted by inserting the non-bsc device into the collar of the guidezilla device; however, due to the damaged stent, the device was not able to be inserted.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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 device analysis completed on 08-feb-2017.It was reported damage occurred on a non bsc device.A 145 guidezilla¿ was used to deliver a non-bsc stent.During the procedure, it was noted that the stent was damaged while passing through the collar.The stent and guidezilla was removed together from the patient body and the patient's condition was stable.However, device analysis revealed a partial 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6349278
• MDR Text Key: 68035569
• Report Number: 2134265-2017-01484
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: H7493924215050
• Device Catalogue Number: 39242-1505
• Device Lot Number: 0020116733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2017
• 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
• Treatment: RESOLUTE (MEDTRONIC) STENT