MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1® FOLEY CATHETER TEMPERATURE SENSOR; CATHETER, UROLOGICAL

Catalog Number	FC400-16
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that the balloon of a level 1® foley catheter temperature sensor burst upon inspection in the patient's bladder.The catheter and balloon pieces were removed.All pieces of the balloon were accounted for.No permanent injury was reported, and the event outcome was reported as resolved.
Additional Manufacturer Narrative
It was determined the reported fault was due to a supplied item.The supplier was notified of the issue.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: LEVEL 1® FOLEY CATHETER TEMPERATURE SENSOR
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6744939
• Report Number: 3012307300-2017-01586
• Device Sequence Number: 771644
• Product Code: KOD
• UDI-Device Identifier: 10695085000501
• UDI-Public: 10695085000501
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K873448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2017

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?: Yes
• Operator of Device: No Information
• Device Catalogue Number: FC400-16
• Device Lot Number: 927504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 10/12/2017
• 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: Required Intervention