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

Model Number H74939335150610

Device Problems Device Damaged by Another Device (2915); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: returned product consisted of a guidezilla guide extension catheter.The device was bloody.The hypotube, collar and tip were microscopically and tactile inspected.Inspection revealed shaft damage (flattened/ovalized) for a length of 37 cm and that included the tip of the device, tip damage (ovalized), and a partial separation in the collar.Functional testing was carried out by loaded a lab supplied stented balloon catheter into the collar of the guidezilla, and the device advanced through the device with a small amount of resistance, but did pass fully through the tip of the device.Inspection of the remainder of the device 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

Same case as mdr id: 2134265-2018-03208.Reportable based on device analysis completed on 30-apr-2018.It was reported that guide wire deformation occurred and advancing difficulties were encountered.The target lesion was located in the moderately tortuous and moderately calcified circumflex artery.After a 6f guidezilla¿ ii long guide extension catheter was advanced, two non-bsc balloon catheters sized 3.75mm and 2.75mm were advanced with two non-bsc guide wires but encountered severe resistance.Subsequently, a 3.00 x 12 synergy¿ drug-eluting stent was advanced but also failed to pass through the guidezilla¿.When the device was removed, the distal part of the stent was found to be lifted.It was also suspected that the inner part of the guidezilla¿ was flattened.The procedure was completed with a non-bsc stent.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed a shaft break.

• Brand Name: GUIDEZILLA¿ II LONG 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: 7531406
• MDR Text Key: 108856133
• Report Number: 2134265-2018-04388
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K163314
• 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: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2020
• Device Model Number: H74939335150610
• Device Lot Number: 21721955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2018
• 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