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

Model Number H7493924215050

Device Problems Kinked (1339); Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the returned product consisted of a guidezilla guide extension catheter.The device was bloody.The hypotube, collar, distal shaft and tip were microscopically and tactile inspected.Inspection revealed tip damage (misshapen/abrasions) with part of the shaft material scrapped off of the markerband, shaft damage (abrasions) and numerous kinks in the distal shaft.The inner diameter (id) of the tip could not be measured due to the damage to the tip, however; the collar id was measured (with a calibrated pin gage) and found to meet guidezilla specifications.Functional testing was carried out by loading a lab supplied stented catheter into the collar of the device.The stented catheter advanced for 5.5 cm, and then stopped advancing at the location of a significant kink in the guidezilla.The damage to the device is consistent with complicated anatomy.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 3-may-2018.It was reported that there was difficulty advancing another device through this catheter due to a device kink.A guidezilla¿ device was selected for use during a percutaneous coronary intervention.The target lesion was located at the mid left circumflex artery (lcx).The physician used a non-bsc device for femoral access.The lesion was predilated using an emerge 2.50 x 15 balloon and later with an emerge 3.50 x 15.The physician then tried to advance a synergy 4.00 x 24 but it could not be delivered to the target lesion.The physician then removed the stent and inserted a guidezilla to help deliver the stent to the target lesion, but the stent could not be advanced through the guidezilla.Upon removal, it was noticed that the guidezilla was kinked.The physician then proceeded to balloon and prepare the lesion further including the bend before the lesion.Finally the physician successfully delivered the same synergy 4.00 x 24 stent to the target lesion.The case was completed after post dilating the stent with nc emerge 4.50 x 12 and 5.00 x 12 devices.No patient complications were reported.The patient's condition after the procedure was stable.However, device analysis revealed that a part of the shaft material was scrapped off of the markerband.

• 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: 7541766
• MDR Text Key: 109187912
• Report Number: 2134265-2018-04533
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K123765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2018

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: 10/17/2019
• Device Model Number: H7493924215050
• Device Catalogue Number: 39242-1505
• Device Lot Number: 21269184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2017
• 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: HEARTRAIL 6F BL3.0 GUIDER -FEMORAL ACCESS