MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC

Model Number	20226
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 10.0x60x75cm express ld iliac / biliary stent was advanced for treatment.However, during deployment, the balloon seemed to have burst.Upon removal, it appeared as though there was a small hole in the part of the balloon.The device was removed from sterile field, wiped twice, and bagged twice.It was noted that the physician was not concerned about any pieces of the balloon remaining in the patient.No patient complications were reported.
Additional Manufacturer Narrative
The complaint was received for analysis.A visual examination of the returned device confirmed that the balloon had been subjected to positive pressure.Blood was observed inside the balloon which is evidence of a device leak.A leak test identified a pinhole in the balloon material located approximately 7mm proximal of the distal markerband.No other issues were noted with the balloon material.The device was received with stent fully deployed from the delivery system as it was implanted inside the patient.A visual examination identified no issues with the tip that could potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft of the device.
Event or Problem Description
It was reported that balloon rupture occurred.A 10.0x60x75cm express ld iliac / biliary stent was advanced for treatment.However, during deployment, the balloon seemed to have burst.Upon removal, it appeared as though there was a small hole in the part of the balloon.The device was removed from sterile field, wiped twice, and bagged twice.It was noted that the physician was not concerned about any pieces of the balloon remaining in the patient.No patient complications were reported.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• 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: 18565235
• Report Number: 2124215-2024-00401
• Device Sequence Number: 20498167
• Product Code: NIO
• UDI-Device Identifier: 08714729392118
• UDI-Public: 08714729392118
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2024

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: 06/15/2024
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0027502338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• 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 Sex: Unknown