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

Model Number M00513860

Device Problems Failure to Advance (2524); Material Twisted/Bent (2981); Positioning Problem (3009); Activation Failure (3270)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2021

Event Type  malfunction  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 281910455
• Report Number: 3005099803-2021-06335
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716082
• UDI-Public: 08714729716082
• Combination Product (y/n): N
• Reporter Country Code: MP
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 12/09/2021
• Supplement Dates FDA Received: 12/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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
• Patient Age: 19 YR
• Patient Sex: Female