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

Model Number UNK963

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id#: 2134265-2018-02261 and 2134265-2018-02329.It was reported that the guide extension catheter damaged another device.The target lesion was located in the circumflex artery.After engaging the lesion with a non-bsc guide catheter and a guidezilla guide extension catheter, a 4.00x12mm synergy ii drug-eluting stent was advanced to treat the lesion.However, the device was not placed correctly and the physician then pulled the stent back through both devices.As the physician put the stent back in, the stent got stripped off the balloon at the transition, at the collar of the guidezilla.The stent was removed with the balloon together.Furthermore, a 4.00x16mm synergy ii drug-eluting stent was advanced; however at some point during the procedure, the physician claimed that when the device was removed the balloon looked larger on either side of the stent.Thus, the physician opted not to use the device.The procedure was completed with another synergy stent.No patient complications were reported and the patient's status was fine.

• Brand Name: GUIDEZILLA¿ II 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: 7376875
• MDR Text Key: 103801296
• Report Number: 2134265-2018-03092
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163314
• 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: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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