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

Model Number	M00513740
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Human-Device Interface Problem (2949); Material Twisted/Bent (2981); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Imdrf impact code f08 is being used to capture the patient's overnight admission for observation.Imdrf device code a1502 captures the reportable event of stent positioning issue.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal distal covered stent was used during an esophageal stenting procedure performed on an unknown date.During the procedure, the physician intended to place a proximal release ultraflex esophageal stent, but a distal release ultraflex esophageal stent was mistakenly placed due to the almost identical packaging of both stents.Consequently, the stent was removed, and an ultraflex proximal release stent was placed.The patient was then admitted overnight for observation.Reportedly, no further intervention was required, and the patient was discharged within 24 hours.There were no known patient complications due to this event.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal distal covered stent was used during an esophageal stenting procedure performed on an unknown date.During the procedure, the physician intended to place a proximal release ultraflex esophageal stent, but a distal release ultraflex esophageal stent was mistakenly placed due to the almost identical packaging of both stents.Consequently, the stent was removed, and an ultraflex proximal release stent was placed.The patient was then admitted overnight for observation.Reportedly, no further intervention was required, and the patient was discharged within 24 hours.There were no known patient complications due to this event.Additional information received on october 28, 2024.The stent was used to treat a 5cm malignant stricture performed on (b)(6) 2024.There were no anatomical problems and the patient's anatomy was dilated prior to stent placement.During the procedure, the stent was unable to fully deploy as the deployment suture was coiled up around the stent causing the shaft to bend.The stent was removed without the use of a retrieval device.
Additional Manufacturer Narrative
Blocks b1, b2 (outcomes attrib to adv event), b3, b5, d4 (model number, lot number, catalog number, expiration date, unique identifier #), e1 (initial reporter title, first name, last name), e3, g4 (premarket/ 510k #), h1, and h6 (impact codes, device codes) have been updated with additional information received on october 28, 2024.Block e1: the second physician is dr.(b)(6).Block h6: imdrf impact code f08 is being used to capture the patient's overnight admission for observation.Imdrf device code a15 captures the reportable event of stent partially deployed.

• 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: 20526665
• Report Number: 3005099803-2024-05250
• Device Sequence Number: 13054257
• Product Code: ESW
• UDI-Device Identifier: 08714729716167
• UDI-Public: 08714729716167
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K130004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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: 02/27/2026
• Device Model Number: M00513740
• Device Catalogue Number: 1374
• Device Lot Number: 0033518414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/21/2024
• Date Device Manufactured: 02/28/2024
• 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 Sex: Unknown