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

Model Number	26280
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 15-jul-2022.It was reported that advancing difficulty was encountered.The target lesion was located in the tracheal bronchus.A 22x70/10fr uni plus 75cm wallstent endoprosthesis was advanced to treat the lesion.However, during the procedure, the stent could not be advanced into the guide catheter.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed stent partial deployment and stent damage.
Additional Manufacturer Narrative
A wallstent uni was returned for analysis.The device was received with the stent partially deployed on the delivery system.The stent was also noted to be damaged.A visual and tactile examination identified no issues with the catheter or delivery system that could potentially have contributed to the complaint incident.The recommended introducer/guide sheath size for this device as per wallstent product specification is minimum 11fr.The investigator was unable to insert the device through a 11fr boston scientific introducer sheath as the stent was partially deployed and was also noted to be damaged.

• 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: 15192939
• Report Number: 2134265-2022-08087
• Device Sequence Number: 5974820
• Product Code: JCT
• UDI-Device Identifier: 08714729204145
• UDI-Public: 08714729204145
• 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
• Report Date (Section B): 08/09/2022

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: 07/22/2023
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0027716325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 65 KG