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

Model Number 26280

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 304906538
• Report Number: 2134265-2022-08087
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 08714729204145
• UDI-Public: 08714729204145
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K152842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 65 KG