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

Model Number M00513730

Device Problems Break (1069); Unraveled Material (1664); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2017

Event Type  Injury  

Manufacturer Narrative

Reported event of stent positioning problem.Investigation finding of stent unraveled.The investigation findings and reported event of stent retention suture broken.Investigation results: a fully deployed ultraflex esophageal distal release stent was received for analysis.The delivery system was not returned.Visual examination of the returned device found the retention sutures on both ends of the stent were broken and the wire loops on both ends of the stent were unraveled.There were no other issues identified during the product analysis the damages noted with the device were consistent with the application of excessive force when repositioning the stent and removing the stent with forceps.The investigation concluded that the observed failures 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 for this complaint is operational context.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.A review of the device history record (dhr) revealed no non-conforming events or deviations.A search of the complaint database confirmed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation on march 17, 2017 that an ultraflex esophageal distal release stent was to be used to treat a malignant tumor in the esophagus during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient's anatomy was tight.According to the complainant, during the procedure, the stent deployment suture broke and the stent was partially deployed.The stent was removed from the patient and the procedure was not completed due to this event.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.Investigation results revealed that the stent retention sutures on both ends of the stent were broken and wire loops on both ends of the stent were unraveled; therefore, this is now an mdr reportable event.Additional information received on april 24, 2017: the complainant confirmed that the ultraflex esophageal distal release stent was fully deployed in the esophagus.After deployment, the physician used forceps to adjust the stent; then, the retention suture detached.

• Brand Name: ULTRAFLEX¿ ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6558641
• MDR Text Key: 74887375
• Report Number: 3005099803-2017-01380
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: (01)08714729716150(17)20171118(10)0018651725
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2017
• Device Model Number: M00513730
• Device Catalogue Number: 1373
• Device Lot Number: 0018651725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention