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 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was retuned for analysis.The tip, distal shaft, collar and hypotube was microscopically and tactfully inspected.The tip is damaged.There are numerous shaft kinks.The stent system that was returned with the guidezilla ii has stent damage preventing the stent system to be inserted into the guidezilla ii.A 4.0mm test device was inserted into the collar of the guidezilla ii and advanced through the entire length of the device with no issues.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

It was reported that the stent became damaged when retracting it into the catheter.The target lesion was located in the severely tortuous and moderately calcified distal right coronary artery.A 6 french guidezilla¿ ii guide extension catheter was selected for use.During the procedure, it was noted that there were difficulties to advance the non-bsc stent into the target lesion.It was also noted that there was resistance when attempts to retract the stent back into the guidezilla were performed.The catheter was then removed out of the patient's body and it was observed that the stent and the tip of the catheter were damaged.The procedure was completed with the same guidezilla and with a different stent.No patient complications were reported and the patient's status was stable.

• 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: 7526195
• MDR Text Key: 108660630
• Report Number: 2134265-2018-04353
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 04/24/2018

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: 10/17/2019
• Device Model Number: H7493933515060
• Device Lot Number: 21402770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2017
• 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: RESOLUTE ONYX