MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number	M00513830
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the reportable investigation finding.Medical device problem code: (b)(4).An ultraflex esophageal ng proximal uncovered stent and delivery system were returned for analysis.The stent was received partially deployed.Visual inspection found the shaft was slightly bent.During functional inspection, the shaft bowed and it was necessary to pull the suture from the distal section to deploy the stent.No other issues were noted to the stent and delivery system.The investigation concluded that procedural factors encountered during the procedure could have limited the performance of the device and contributed to stent partial deployment and the bent shaft.It may be that handling and manipulation of the device during the procedure could have caused the bent shaft and difficulty in deploying the stent resulting to the stent being partially deployed.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
This ultraflex esophageal ng proximal release stent was returned to boston scientific corporation without any report of performance issues or adverse patient effects.The returned device was analyzed and the stent was partially deployed and the shaft was slightly bent.This event has been deemed a reportable event based on the investigation finding of stent partially deployed.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13599261
• Report Number: 3005099803-2022-00998
• Device Sequence Number: 1956379
• Product Code: ESW
• UDI-Device Identifier: 08714729716204
• UDI-Public: 08714729716204
• Combination Product (Y/N): N
• Initial Reporter Country: MO
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2022
• Device Model Number: M00513830
• Device Catalogue Number: 1383
• Device Lot Number: 0025468098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown