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

Model Number	26280
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Device evaluated by manufacturer: a wallstent uni device was received for analysis.A visual and tactile examination of catheter/delivery system identified multiple outer sheath kinks along the length of the shaft.The inner sheath was also noted to be damaged.The device was received with the stent unsheathed on the device.The investigator was able to deploy the stent.The stent was noted to be damaged on the distal end.
Event or Problem Description
Reportable based on device analysis completed on 25sep2023.It was reported that partial deployment occurred.The target lesion was occluded with tumor compression located in the superior vena cava.A 22x45/10fr uni plus 75cm wallstent endoprosthesis stent was advanced for treatment.However, when attempted to deploy the stent, resistance was encountered, and found the shape of the stent was not good and the tip could not be fully opened.The procedure was competed with another of the same device.There were no patient complications reported and the patient was stable.However, returned device revealed stent was damaged.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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: 17957779
• Report Number: 2124215-2023-52252
• Device Sequence Number: 17894354
• Product Code: JCT
• UDI-Device Identifier: 08714729204138
• UDI-Public: 08714729204138
• 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
• Report Date (Section B): 10/18/2023

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: 09/20/2023
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0028051128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 66 KG