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 Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id: 2134265-2018-03565.It was reported that the stent became caught on the catheter and damage occurred.The target lesion was located in the calcified ostial right coronary artery.A 4.00 x 28mm synergy ii drug-eluting stent was advanced through a 6f guidezilla¿ ii guide extension catheter.However, it was noted that the stent penetrated the calcium and the distal edge of the stent was dinged up.When the device was removed, the proximal end got caught on the guidezilla ii guide extension catheter and the stent was squashed or squeezed.The physician removed the entire system out and then re-engaged and completed the procedure with a 4.00 x 12mm synergy ii drug-eluting stent.No patient complications were reported and the patient's status was fine.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a 6f guidezilla 2 guide extension catheter plus a synergy stented balloon catheter that was protruding out of the guidezilla tip approximately 32 mm.There was blood inside and outside of the device, and the device were separated during the lab analysis.The hypotube, collar, distal shaft and tip was microscopically and tactile inspected.Inspection revealed tip damage(misshapen/notched/abrasions), and flattened distal shaft located 30 mm and 53 mm from the tip of the device.The collar inner diameter (id) was measured with a calibrated pin gage, and found to have an id of.057¿ meeting specification.The damage to the tip was caused due to the synergy stent ¿lifting¿ and catching on the tip of the guidezilla, and not allowing the stented device to withdraw back into the guidezilla shaft.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-03565.It was reported that the stent became caught on the catheter and damage occurred.The target lesion was located in the calcified ostial right coronary artery.A 4.00 x 28mm synergy ii drug-eluting stent was advanced through a 6f guidezilla ii guide extension catheter.However, it was noted that the stent penetrated the calcium and the distal edge of the stent was dinged up.When the device was removed, the proximal end got caught on the guidezilla ii guide extension catheter and the stent was squashed or squeezed.The physician removed the entire system out and then re-engaged and completed the procedure with a 4.00 x 12mm synergy ii drug-eluting 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: 7471979
• MDR Text Key: 106861232
• Report Number: 2134265-2018-03568
• 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,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2020
• Device Model Number: H7493933515060
• Device Lot Number: 21726160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2018
• 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