MAUDE Adverse Event Report: MEDTRONIC IRELAND RACER OTW; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	XD618YF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	08/11/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigator assessment is based on study device and not the renal non-study stent implanted during index procedure.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During procedure, a racer stent was implanted in the left renal artery.Three days post procedure, patient had urinary tract infection.Patient was treated with medication and event was resolved.Investigator assessed event is related to the procedure and not device.No additional clinical sequelae was reported.Patient recovered.
Additional Manufacturer Narrative
Additional information: the patient had a small urinary tract infection after being discharged from the hospital and was treated with oral antibiotics.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RACER OTW
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9225804
• Report Number: 9612164-2019-04478
• Device Sequence Number: 1891912
• Product Code: FGE
• UDI-Device Identifier: 00613994551481
• UDI-Public: 00613994551481
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K032768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/26/2015
• Device Catalogue Number: XD618YF
• Device Lot Number: 0006696655
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 93