MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS VASCULAR SD; CATHETER, BILIARY, DIAGNOSTIC

Model Number 20201

Device Problem Leak/Splash (1354)

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

Event Date 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

Returned product consisted of an express sd balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole 7mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found a pinhole in the balloon.

Event Description

Reportable based on the device analysis completed on (b)(6) 2024.It was reported that balloon leak occurred.The patient was diagnosed with fibrosing mediastinitis and pulmonary vein stenosis.Interventional treatment with pulmonary vein stent placement was performed under general anesthesia.The lesion site was mildly tortuous and moderately calcified.After placing an 8f non-boston scientific (bsc) guide catheter, a 0.14 guidewire was used to cross the lesion.Following balloon pre-dilatation, a 7.0mmx19mmx150cm express vascular sd stent was advanced for treatment.However, during inflation at 4 atmospheres, the image showed that the contrast agent leaked from the stent balloon tip.After withdrawal, visual inspection found liquid leakage, but no visible pinhole was noted.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.However, returned device analysis revealed a pinhole 7mm from the tip.

• Brand Name: EXPRESS VASCULAR SD
• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18893002
• MDR Text Key: 337522314
• Report Number: 2124215-2024-15165
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20201
• Device Catalogue Number: 20201
• Device Lot Number: 0031103587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2023
• 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
• Treatment: GUIDE CATHETER - COOK 8F
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 62 KG