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

Model Number	20188
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: used the 1st day of the month of the bsc aware date as no event date was provided.
Event or Problem Description
It was reported that stent dislodgement occurred.A 5.0mmx19mmx90cm express sd renal/biliary stent was advanced for treatment.However, during the procedure the stent came off the balloon before it was deployed.The physician removed the stent with a retrieval device.No further patient complications were reported.
Additional Manufacturer Narrative
(b3) date of event: used the 1st day of the month of the bsc aware date as no event date was provided.Device evaluated by mfr.: returned product consisted of an express sd stent delivery system (sds) without the stent.Visual and microscopic inspection revealed that there was stent impressions on the balloon indicating that the stent was secure on the balloon.There was no damage to the sds.
Event or Problem Description
It was reported that stent dislodgement occurred.A 5.0mmx19mmx90cm express sd renal/biliary stent was advanced for treatment.However, during the procedure the stent came off the balloon before it was deployed.The physician removed the stent with a retrieval device.No further 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: 9793760
• Report Number: 2134265-2020-02611
• Device Sequence Number: 2573712
• Product Code: NIN
• UDI-Device Identifier: 08714729390480
• UDI-Public: 08714729390480
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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: 04/30/2020
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0020496511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 12/07/2020
• 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: Other