MAUDE Adverse Event Report: DIVERSATEK HEALTHCARE M-FLEX SILICONE BOUGIE; ESOPHAGEAL BOUGIE

Model Number	1206-54
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer contacted diversatek healthcare on (b)(6) and stated the tip had detached from the catheter shaft when the bougie was being inserted prior to a surgical procedure.The user facility stated, "the bougie was being inserted and resistance was met at a short distance.When pulling it out, a six inch segment of the distal end remained.The tip could be seen in the mouth and was removed by hand.While the patient remained intubated the airway was irrigated and suctioned.A bronchoscopy and endoscopy was performance with no damage noted." while the device was not returned for evaluation, the user facility did send pictures of the device.The device broke at the bonded junction between the molded silicone distal tip and the molded proximal silicone catheter shaft.This device is weighted with tungsten powder to aid in placement during 'blind' esophageal dilatations.The tungsten powder is non-toxic and an sds is available on the diversatekhealthcare.Com website.The sds was also sent to the user on (b)(6) when they reported the event.The sds states the tungsten is non-toxic and there are no potential health effects from inhalation and possible gastrointestinal irritation with ingestion.Diversatek healthcare performed an investigation by reviewing the pictures provided by the user facility, production records of this lot, the manufacturing process, and the device design.This reusable device was manufactured and sold in 2019.The shelf life of this device is 3 years and this device had been approximately 20 months old at the time of this event.The device history record of the production lot was reviewed and no issues were recorded.The manufacturing process was investigated and no issues were noted.The current design of this device joint is used in (b)(4) different sizes/styles of this device on the market since 2007 and this is the only reported incident of separation of this joint.The tungsten powder is specifically used as the fill material because it is non-toxic.Based on a review of the trending reports and the information available, the cause of this malfunction is not believed to be any systemic issue related to design or manufacturing.Diversatek healthcare has determined that there are no new safety or efficacy issues as a result of this event, and therefore, no future action will be taken.
Event or Problem Description
Per sus voluntary event report mw5101618 from (b)(6): "endoscopy bougie being used in surgical case was being removed when the tip came off.The tip was retrieved, however, tungsten powder from the bougie was noted in the pt's mouth.".

• Brand Name: M-FLEX SILICONE BOUGIE
• Common Device Name: ESOPHAGEAL BOUGIE
• Manufacturer (Section D): DIVERSATEK HEALTHCARE; 102 e keefe ave; milwaukee WI 53212
• MDR Report Key: 12078869
• Report Number: 2183446-2021-00001
• Device Sequence Number: 3464982
• Product Code: FAT
• UDI-Device Identifier: 00816734020173
• UDI-Public: 00816734020173
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K972119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/28/2021

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: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 1206-54
• Device Catalogue Number: 1206-54
• Device Lot Number: 224102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/28/2021
• 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