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

Model Number	20188
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device contamination occurred.A 6.0mmx18mmx150cm express sd renal/biliary drug eluting was selected for use.However, before it went to the body, the device got contaminated.The procedure was completed with another of same device.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an express sd stented catheter in an opened pouch.The device was removed from the carrier tubing revealing that the balloon was loosely folded.The stent was secured between the markerbands.The opened packaging, hypotube, outer shaft, inner shaft, balloon, stent and tip were visually and microscopically examined.Inspection of the device presented no damage or irregularities.
Event or Problem Description
It was reported that device contamination occurred.A 6.0mmx18mmx150cm express sd renal/biliary drug eluting was selected for use.However, before it went to the body, the device got contaminated.The procedure was completed with another of same device.

• 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: 8546895
• Report Number: 2134265-2019-04307
• Device Sequence Number: 16755062
• Product Code: NIN
• UDI-Device Identifier: 08714729484844
• UDI-Public: 08714729484844
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152607
• 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): 07/29/2019

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: 01/03/2022
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0023138186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1