MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GUIDEZILLA II; CATHETER, PERCUTANEOUS

Model Number 1871

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2020

Event Type  malfunction  

Event Description

It was reported that the guidezilla dislodged the original synergy stent and had to be snared.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified diagonal of left anterior descending artery.A guidezilla ii catheter guide extension and a synergy drug-eluting stent were selected for use.During procedure, the stent would not advance further into the lesion so the doctor took the guidezilla 6f.The guidezilla was inserted into the proximal part of the stent and they tried to advance it further into the lesion, however resistance was felt.The guidezilla and stent were removed together and it was noted that the stent was not attached to the delivery system.It was noticed that the stent was partially unraveled and distorted.A snaring device was used to remove the stent out.The procedure was completed with another synergy stent.No patient complications were reported.

• Brand Name: GUIDEZILLA II
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10734118
• MDR Text Key: 213018259
• Report Number: 2134265-2020-14724
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K163314
• 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: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1871
• Device Catalogue Number: 1871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2020
• 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
• Treatment: STENT BALLOON EXPANDABLE: SYNERGY