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

Model Number M00513860

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2015-01788 and 3005099803-2015-01789 for the associated device information.It was reported to boston scientific corporation that two ultraflex¿ esophageal ng stents were used to treat a malignant stricture in the esophagus during an esophageal stent implantation procedure performed on (b)(6) 2015.According to the complainant, during the procedure the physician noted that the first ultraflex¿ esophageal ng stent (the subject of mfr report # 3005099803-2015-01788) would not cross the stenosis.The stent was removed without any issues and the physician dilated the stenosis with a cre balloon.After dilation a second attempt was made to cross the stenosis with the same ultraflex¿ esophageal ng stent, but was unsuccessful.During the second attempt, the physician noted that the dilation tip was bent.The device was removed again without any problems.An attempt was then made to use a shorter ultraflex stent (the subject of mfr report #3005099803-2015-01789), but the dilation tip also bent trying to cross through the stenosis.The device was removed without any issues.The physician chose to not attempt to place another stent at this time.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 and the patient was prescribed to receive medical palliative treatment.

Manufacturer Narrative

Exact patient age is unknown; however, the patient was reported to be over 18 years old.Reported event of tip bent.The device has been received for analysis; however, 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 medwatch will be filed.

Manufacturer Narrative

An ultraflex¿ esophageal ng stent was returned for analysis.The stent was fully crocheted onto the returned device.No issues were noted with profile of delivery system shaft, the crocheted section of the device or the tip.It was noted that the deployment suture was detached from the distal silastic tubing which may have occurred during the difficulty crossing the lesion.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.The noted damages indicate difficulty was experienced during deployment and are likely due to anatomical or procedural factors such as tortuous anatomy or maneuvering of the device.Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2015-01788 and 3005099803-2015-01789 for the associated device information.It was reported to boston scientific corporation that two ultraflex esophageal ng stents were used to treat a malignant stricture in the esophagus during an esophageal stent implantation procedure performed on (b)(6) 2015.According to the complainant, during the procedure the physician noted that the first ultraflex esophageal ng stent (the subject of mfr report # 3005099803-2015-01788) would not cross the stenosis.The stent was removed without any issues and the physician dilated the stenosis with a cre balloon.After dilation a second attempt was made to cross the stenosis with the same ultraflex esophageal ng stent, but was unsuccessful.During the second attempt, the physician noted that the dilation tip was bent.The device was removed again without any problems.An attempt was then made to use a shorter ultraflex stent (the subject of mfr report #3005099803-2015-01789), but the dilation tip also bent trying to cross through the stenosis.The device was removed without any issues.The physician chose to not attempt to place another stent at this time.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 and the patient was prescribed to receive medical palliative treatment.

• Brand Name: ULTRAFLEX¿ ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4861866
• MDR Text Key: 5862972
• Report Number: 3005099803-2015-01788
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: UY
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2015

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
• Device Operator: Physician
• Device Expiration Date: 01/20/2017
• Device Model Number: M00513860
• Device Catalogue Number: 1386
• Device Lot Number: 17622187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2015
• 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