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

Model Number H7493933515060

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id 2134265-2018-05482.It was reported that the shaft of the synergy broke upon removal from the guidezilla.The target lesion was extremely tortuous.A 6f guidezilla¿ ii guide extension catheter and 4.00 x 24 synergy ii drug-eluting stent were selected for the percutaneous coronary intervention (pci) procedure.After deploying the stent, and upon removal of the stent delivery system (sds) through the distal portion of the guidezilla, the shaft of the sds broke.Due to having an unspecified buddy wire in the guidezilla , there was very little head room.Also while trying to pull the sds out, drag was encountered due to the extremely tortuous vessel.The procedure was completed successfully.No patient complications reported.

Event Description

Same case as mdr id 2134265-2018-05482.It was reported that the shaft of the synergy broke upon removal from the guidezilla.The target lesion was extremely tortuous.A 6f guidezilla¿ ii guide extension catheter and 4.00 x 24 synergy ii drug-eluting stent were selected for the percutaneous coronary intervention (pci) procedure.After deploying the stent, and upon removal of the stent delivery system (sds) through the distal portion of the guidezilla, the shaft of the sds broke.Due to having an unspecified buddy wire in the guidezilla , there was very little head room.Also while trying to pull the sds out, drag was encountered due to the extremely tortuous vessel.The procedure was completed successfully.No patient complications reported.

Manufacturer Narrative

Updated: device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes.Device evaluated by mfr: the device was returned for analysis.Returned product consisted of a 6f guidezilla 2 guide extension catheter with two unidentified guide wire and the distal end of the related synergy stented balloon catheter were all inside the guidezilla distal shaft.The hypotube, collar, distal shaft and tip was microscopically and tactile inspected.Inspection revealed tip damage (flattened/abrasions/notched/ misshapen), distal shaft damage (abrasions), and collar damage (distal shaft material was pushed inward).The collar inner diameter (id) was measured using a calibrated pin gage, and the collar was found to be measuring.057¿ and met specification.The tip of the device could not be pinned due to the excessive damage.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Functional testing was conducted with a lab supplied, test 4.0 mm stented catheter.The test device was loaded into the collar and advanced easily until approximately 4 mm from the tip.Additional force was applied, and the test device did exit out from the tip of the guidezilla.The test device was then withdrawn with extra manipulation/force.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).

• 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
• MDR Report Key: 7627106
• MDR Text Key: 112053836
• Report Number: 2134265-2018-05466
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

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: 03/11/2020
• Device Model Number: H7493933515060
• Device Lot Number: 0021982646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 07/03/2018
• Supplement Dates FDA Received: 07/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1