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

Model Number 26280

Device Problems Tear, Rip or Hole in Device Packaging (2385); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/12/2023

Event Type  malfunction  

Event Description

It was reported that damage on the inner package occurred.A 16x90/9fr uni plus 75cm wallstent uni was selected for the treatment on the iliac vein.When it was unpacked for preparation, a damage was noted as there was a visible hole on the inner packaging, compromising the device sterility.The procedure was completed with another of the same device.No complications were reported, and the patient was in a stable condition.

Manufacturer Narrative

The wallstent uni was received by the manufacturer for a device analysis.The device packaging was discarded by the customer and not returned for analysis.A visual and tactile examination identified that there was a kink in the outer sheath approximately 600mm proximal from the distal tip of the device.

Event Description

It was reported that damage on the inner package occurred.A 16x90/9fr uni plus 75cm wallstent uni was selected for the treatment on the iliac vein.When it was unpacked for preparation, a damage was noted as there was a visible hole on the inner packaging, compromising the device's sterility.The procedure was completed with another of the same device.No complications were reported, and the patient was in a stable condition.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Type of Device: 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: 18446035
• MDR Text Key: 331928338
• Report Number: 2124215-2023-75215
• Device Sequence Number: 1
• Product Code: MAF
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0030809088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2023
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 64 KG