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

Model Number	26280
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6) hospital.
Event or Problem Description
It was reported that inadvertent deployment occurred.The procedure was performed via selective venography.The 70% stenosed target lesion was located in the mildly tortuous and non-calcified venous thrombosis of lower extremity.A 12x90/8fr uni plus halo 75cm wallstent uni was selected for use.It was during procedure that it was found that the stent was unintentionally deployed outside the patient's body.The procedure was completed with a different device and no patient complications were reported.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: the device was returned for analysis.It was returned with the stent fully deployed from the delivery system.The deployed stent was not returned for analysis.A visual examination identified no damage or issues with the stent cups or stent holder of the returned device.A visual and tactile examination identified no issues with the tip and sheath of the device.
Event or Problem Description
It was reported that inadvertent deployment occurred.The procedure was performed via selective venography.The 70% stenosed target lesion was located in the mildly tortuous and non-calcified venous thrombosis of lower extremity.A 12x90/8fr uni plus halo 75cm wallstent uni was selected for use.It was during procedure that it was found that the stent was unintentionally deployed outside the patient's body.The procedure was completed with a different device and no patient complications were reported.

• 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: 18367467
• Report Number: 2124215-2023-71979
• Device Sequence Number: 8109178
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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: 01/29/2025
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0030943712
• 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: 11/28/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 65 KG