MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT RP ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	26265
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.The patient presented with pancreatic space occupying lesion, obstructive jaundice, and hypertension.The target lesion was located in the biliary tract.The patient was placed in a supine position for percutaneous stent implantation.After placing an 035 guidewire and a 6f-long sheath, an 8x60x75/ 6f wallstent rp endoprosthesis was selected for use.However, during preparation, it was found that the protective sheath of the stent was fractured.The device was replaced with another of same device, and the procedure was completed.There were no complications reported and the patient status was stable.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.The device was returned for evaluation.A visual and tactile examination identified that there was an outer sheath break 30mm distal from the distal end of hub.The device was received with the stent sheathed on the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred.The patient presented with pancreatic space occupying lesion, obstructive jaundice, and hypertension.The target lesion was located in the biliary tract.The patient was placed in a supine position for percutaneous stent implantation.After placing an 035 guidewire and a 6f-long sheath, an 8x60x75/6f wallstent rp endoprosthesis was selected for use.However, during preparation, it was found that the protective sheath of the stent was fractured.The device was replaced with another of same device, and the procedure was completed.There were no complications reported and the patient status was stable.

• Brand Name: WALLSTENT RP ENDOPROSTHESIS
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19053232
• Report Number: 2124215-2024-18634
• Device Sequence Number: 15221225
• Product Code: FGE
• UDI-Device Identifier: 08714729406396
• UDI-Public: 08714729406396
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2025
• Device Model Number: 26265
• Device Catalogue Number: 26265
• Device Lot Number: 0032408171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• 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
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 71 KG