MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO FATHOM SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number 29462

Device Problems Contamination (1120); Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 07/25/2020

Event Type  malfunction  

Event Description

It was reported that the seal was compromised.A 180cm/135cm renegade hi-flo fathom system was selected for use.Upon unpacking, it was noted that the device had passed the device deadline and the seal was compromised.The procedure was completed with a different device.No complications reported and patient was stable.

• Brand Name: RENEGADE HI-FLO FATHOM SYSTEM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10455120
• MDR Text Key: 204402529
• Report Number: 2134265-2020-11672
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729790860
• UDI-Public: 08714729790860
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K140329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2020

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: 03/31/2020
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0020469248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2017
• 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
• Patient Age: 38 YR
• Patient Weight: 52