MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX¿ ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number	M00514210
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported issue of stent deployment suture broken.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(4) 2016 that an ultraflex¿ esophageal stent was to be used to treat a 6 cm malignant stricture in the middle third part of the esophagus during a therapeutic gastroscopy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the physician started deploying the stent but the stent would not deploy.The physician removed the entire device from the patient and noted that the stent deployment suture broke.The procedure was completed with a wallflex stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Investigation results: an ultraflex esophageal distal release stent and delivery system was returned for analysis.The device was received not deployed.Visual evaluation found the shaft was kinked at multiple places.Functional analysis found that the shaft bowed during a failed deployment attempt.It was possible to manually deploy the stent by pulling directly on the deployment suture.There was no damage to or issue with the deployment suture, and no other issues were noted with the device.The investigation concluded that the observed damages are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2016 that an ultraflex¿ esophageal stent was to be used to treat a 6 cm malignant stricture in the middle third part of the esophagus during a therapeutic gastroscopy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the physician started deploying the stent but the stent would not deploy.The physician removed the entire device from the patient and noted that the stent deployment suture broke.The procedure was completed with a wallflex stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: ULTRAFLEX¿ ESOPHAGEAL NG
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6157584
• Report Number: 3005099803-2016-03766
• Device Sequence Number: 1070383
• Product Code: ESW
• UDI-Device Identifier: 08714729121206
• UDI-Public: (01)08714729121206(17)20170116(10)17614002
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2016

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: 01/16/2017
• Device Model Number: M00514210
• Device Catalogue Number: 1421
• Device Lot Number: 17614002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2016
• Supplement Report FDA Received Date: 01/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR