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

Model Number	M00513860
Medical Device Problem Codes	Failure to Advance (2524); Material Twisted/Bent (2981); Positioning Problem (3009); Activation Failure (3270)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be file.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that an ultraflex esophageal ng proximal release covered stent was to be implanted to treat a malignant esophageal stenosis during a gastroscopy procedure performed on (b)(6) 2021.During the procedure, there was difficulty advancing the delivery system through the stricture.The distal part of the delivery system was bent and the stent was deployed in an incorrect location.It was observed under direct visualization with a pediatric gastroscope that the stent did not fully expand.The stent was removed from the patient using a re-usable grasping forceps and the procedure was cancelled.A non-serious injury was reported related to the event.
Event or Problem Description
It was reported to boston scientific corporation on november 15,2021 that an ultraflex esophageal ng proximal release covered stent was to be implanted to treat a malignant esophageal stenosis during a gastroscopy procedure performed on (b)(6) 2021.During the procedure, there was difficulty advancing the delivery system through the stricture.The distal part of the delivery system was bent and the stent was deployed in an incorrect location.It was observed under direct visualization with a pediatric gastroscope that the stent did not fully expand.The stent was removed from the patient using a re-usable grasping forceps and the procedure was cancelled.A non-serious injury was reported related to the event.Additional information received on december 09, 2021: it was confirmed that there were no injury and no patient complications as a result of this event.Additionally, it is unknown if the stent was removed from the patient.
Additional Manufacturer Narrative
Blocks b1, b2 (outcomes attributed to adverse event), b5, e1 (initial reporter's first name), h1, and h6 ( patient codes and impact codes) have been updated with additional information received on december 09, 2021.Block h6: medical device problem code a1502 captures the reportable event of stent positioning issue.Medical device problem code a150101 captures the reportable event of stent failure to expand.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be file.Block h11: block g2 (report source) has been corrected.

• 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: 12960099
• Report Number: 3005099803-2021-06335
• Device Sequence Number: 1854626
• Product Code: ESW
• UDI-Device Identifier: 08714729716082
• UDI-Public: 08714729716082
• Combination Product (Y/N): N
• Initial Reporter Country: MP
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2021

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: 06/16/2023
• Device Model Number: M00513860
• Device Catalogue Number: 1386
• Device Lot Number: 0027500847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 12/31/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 19 YR
• Patient Sex: Female