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

Model Number H7493924215050

Device Problems Difficult to Insert (1316); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2015

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: returned product consisted of a guidezilla guide extension catheter and a non-bsc guide catheter.Microscopic examination and tactile inspection revealed numerous kinks throughout the shaft.The shaft was partially separated from the collar of the device.Microscopic inspection found no irregularities or damage.Functional testing was performed by inserting the distal end of the guidezilla through the hub of the guide catheter.The guidezilla was able to be inserted; however, due to the numerous kinks in the shaft the functional test was unable to be performed any farther.The maximum outer diameter (od) of the guidezilla distal shaft exceeded guidezilla specification.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

It was reported that the device was not able to come out from the guide catheter.The 90% stenosed target lesion was located in the moderately calcified and moderately tortuous mid left anterior descending (lad) artery.During a percutaneous coronary intervention (pci), a 5-in-6 guidezilla¿ guide extension catheter was attempted to be delivered using a 6fr 3.5 ebu non-bsc guide catheter.The physician could deliver the device to the proximal site of the lesion at first usage.The device was able to be removed from the patient and was attempted to be delivered to the lesion again.However, the device was not able to come out from the guide catheter and was unable to be delivered to the coronary artery.However, device analysis revealed that the shaft was partially separated from 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: 5305722
• MDR Text Key: 33729629
• Report Number: 2134265-2015-08743
• 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: 11/30/2015

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: 06/30/2017
• Device Model Number: H7493924215050
• Device Catalogue Number: 39242-1505
• Device Lot Number: 18079130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/17/2015
• Date Device Manufactured: 06/15/2015
• 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
• Treatment: 6FR EBU3.5 LAUNCHER