MAUDE Adverse Event Report: MEDOVATIONS; BOUGIE

Device Problem Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Date 04/22/2014

Event Type  Injury  

Event Description

Pt underwent repair of a large incarcerated paraesophageal hernia.While passing 24f bougie down esophagus, a perforation was noted.Procedure was converted from laparoscopic to open approach.

Manufacturer Narrative

Hospital was unable to provide exact part number and lot number of 24fr bougie and part was not returned for eval.A review of shipment records to this customer shows the likely device to be part number 1208-24 and lot number 212841, shipped on (b)(4) 2012.The bougies are a reusable devices, labeled with a 3 year expiration date.Pt esophageal perforation was repaired with 4 sutures during open approach of hernia repair procedure.Pt did not receive any additional treatment.There was no malfunction of the device and the device did not cause or contribute to the injury.

• Brand Name: NI
• Type of Device: BOUGIE
• Manufacturer (Section D): MEDOVATIONS; milwaukee WI
• Manufacturer Contact: laura boll ; 102 east keefe ave.; milwaukee, WI 53212 ; 4147554806
• MDR Report Key: 4080746
• MDR Text Key: 17264063
• Report Number: 2183446-2014-00001
• Device Sequence Number: 1
• Product Code: FAT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/23/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2014
• Date Manufacturer Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention