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

Model Number	20188
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break, stent dislodgement occurred.The stenosed target lesion was located in the moderately tortuous and severely calcified iliac vein.A 6.0mmx14mmx90cm express sd stent was advanced but the shaft broke and lost push ability.During removal, the stent came off the catheter.The physician then used an opticross 18 intravascular ultrasound (ivus) to look on the stent but the ivus got stuck in the lesion and the screen went black.Subsequently, a 7.0mmx15mmx90cm express sd stent was used to tack up the smaller stent but it also broke during deployment and had to be removed.The procedure was completed using additional sd stent.No patient complications were reported.

• Brand Name: EXPRESS SD RENAL/BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12260323
• Report Number: 2134265-2021-09633
• Device Sequence Number: 4066792
• Product Code: NIN
• UDI-Device Identifier: 08714729484837
• UDI-Public: 08714729484837
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2024
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0026583562
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention