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

Model Number	20188
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the renal artery.A 5.0mmx15mmx150cm express sd stent was advanced for treatment but could not get through from aorta to the right place as the curve was too big.It was noted that the catheter french was too stiff.The device was pulled out immediately and there were no trauma to any tissue occurred.The procedure was not completed due to this event.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the renal artery.A 5.0mmx15mmx150cm express sd stent was advanced for treatment but could not get through from aorta to the right place as the curve was too big.It was noted that the catheter french was too stiff.The device was pulled out immediately and there were no trauma to any tissue occurred.The procedure was not completed due to this event.No patient complications were reported and the patient's status was stable.It was further reported that the 50% stenosed target lesion was severely tortuous and non-calcified.The procedure was not completed because the renal artery was too tortuous and the catheter was too stiff to enter.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the renal artery.A 5.0mmx15mmx150cm express sd stent was advanced for treatment but could not get through from aorta to the right place as the curve was too big.It was noted that the catheter french was too stiff.The device was pulled out immediately and there were no trauma to any tissue occurred.The procedure was not completed due to this event.No patient complications were reported and the patient's status was stable.It was further reported that the 50% stenosed target lesion was severely tortuous and non-calcified.The procedure was not completed because the renal artery was too tortuous and the catheter was too stiff to enter.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device evaluation 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 and microscopic examination revealed no 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: 10431397
• Report Number: 2134265-2020-11381
• Device Sequence Number: 11364573
• Product Code: NIN
• UDI-Device Identifier: 08714729390398
• UDI-Public: 08714729390398
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K152607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2020

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: 09/30/2021
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0022727869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 08/16/2020
• Supplement Date Received by Manufacturer: 08/19/2020; 10/21/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 08/25/2020; 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1