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

Model Number	20188
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon removal difficulties were encountered.The target lesion was located in the renal artery.Pre- dilatation with a 4x20mm balloon was performed at 8 and 14 atmospheres.A 6.0mmx14mmx150cm express sd renal/biliary stent catheter was advanced for treatment.The stent was placed using a v18 wire at 10 atmospheres.However, the physician had difficulty removing the balloon shaft.The device was challenging to remove and took 20 minutes, while the sheath and wire were removed easily.No patient complications were reported.
Event or Problem Description
It was reported that balloon removal difficulties were encountered.The target lesion was located in the renal artery.Pre- dilatation with a 4x20mm balloon was performed at 8 and 14 atmospheres.A 6.0mmx14mmx150cm express sd renal/biliary stent catheter was advanced for treatment.The stent was placed using a v18 wire at 10 atmospheres.However, the physician had difficulty removing the balloon shaft.The device was challenging to remove and took 20 minutes, while the sheath and wire were removed easily.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: 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 that the inflation lumen is stretched and twisted 70cm from the hub.There are multiple kinks along the shaft of the device.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no damage or irregularities.

• 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: 12388694
• Report Number: 2134265-2021-10871
• Device Sequence Number: 11924450
• Product Code: NIN
• UDI-Device Identifier: 08714729484820
• UDI-Public: 08714729484820
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K152607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

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: 03/30/2023
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0025422126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1