MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE STC 18; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 80617

Device Problem Contamination (1120)

Patient Problem No Patient Involvement (2645)

Event Date 09/02/2018

Event Type  malfunction  

Event Description

It was reported that inner package of device was found contaminated.A renegade stc 18 was used for embolization.During unpacking, it was found out that the inner package of the device was contaminated.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Event Description

It was reported that inner package of device was found contaminated.A renegade stc 18 was used for embolization.During unpacking, it was found out that the inner package of the device was contaminated.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.The device was returned for evaluation without the packaging.The hub, shaft and tip were microscopically examined.The device showed multiple kinks on the shaft from the tip, proximally 26cm.The packaging was not returned; therefore, the complaint could not be confirmed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• Brand Name: RENEGADE STC 18
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7910686
• MDR Text Key: 121860255
• Report Number: 2134265-2018-61302
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729444442
• UDI-Public: 08714729444442
• Combination Product (y/n): N
• PMA/PMN Number: K023681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2020
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0021104627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Date Manufacturer Received: 09/28/2018
• Patient Sequence Number: 1