MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	26280
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that stent damage occurred.During unpacking of a 12x90/8fr uni plus halo 75cm wallstent endoprosthesis, it was noted that the stent struts were damaged.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: a 12x90/8fr uni plus halo 75cm was received for analysis.The device was received with the stent mounted in the correct position on the delivery system.The investigator was unable to deploy the stent as indicated in the instructions for use due to a severe kink to the stainless-steel shaft.To facilitate analysis of the stent the investigator dissected the shaft of the device and deployed the stent by grasping the tip and withdrawing the inner shaft.A visual examination of the stent found no issues or damage to the stent.A visual and tactile inspection found the shaft of the device to be severely kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.A visual and tactile examination identified no issues with the tip of the device.
Event or Problem Description
It was reported that stent damage occurred.During unpacking of a 12x90/8fr uni plus halo 75cm wallstent endoprosthesis, it was noted that the stent struts were damaged.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15018244
• Report Number: 2124215-2022-24029
• Device Sequence Number: 6041259
• Product Code: MAF
• UDI-Device Identifier: 08714729203971
• UDI-Public: 08714729203971
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022
• 2 Devices were Involved in the Event: 1 2

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: 12/18/2022
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0026540323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2020
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 69 KG