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

Model Number	20226
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon detachment occurred.Vascular access has obtained via the radial artery.The target lesion was located in the subclavian artery.A 8.0 x 30 x 75 cm express ld iliac / biliary stent was advanced and successfully deployed.However, upon removal of the balloon catheter through the sheath in the radial artery, the balloon came off the catheter delivery system and was stuck in the sheath.The detached balloon was removed upon removal of the sheath and the procedure completed.There were no patient complications reported and the patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The device was returned advanced through the customers 6fr introducer sheath.The recommended sheath size is a 6fr introducer sheath.The sheath used by the customer was not returned for analysis.A visual and microscopic examination identified that the balloon had been inflated.No issues were identified with the balloon material that may have contributed to the complaint incident.The stent of the device was not returned as it was successfully implanted in the patient.A visual and microscopic examination identified no issues with the tip of the that could have contributed to the complaint incident.A visual and tactile examination found the shaft of the device to be stretched and completely detached at the proximal balloon bond.This type of damage is consistent with excessive tensile force being applied to the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon detachment occurred.Vascular access has obtained via the radial artery.The target lesion was located in the subclavian artery.A 8.0x30x75cm express ld iliac / biliary stent was advanced and successfully deployed.However, upon removal of the balloon catheter through the sheath in the radial artery, the balloon came off the catheter delivery system and was stuck in the sheath.The detached balloon was removed upon removal of the sheath and the procedure completed.There were no patient complications reported and the patient was fine.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8851214
• Report Number: 2134265-2019-09085
• Device Sequence Number: 11139227
• Product Code: NIO
• UDI-Device Identifier: 08714729579670
• UDI-Public: 08714729579670
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

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: 09/25/2021
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0022702107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1