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 Patient Involvement (2645)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.During preparation of a 6.0mmx14mmx90cm express sd renal/biliary stent, the physician removed the plastic covering that was on top of the stent and at the same time the stent came with it.The device was replaced with another of the same device to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the product was not received for analysis.However, there was a photo of the complaint device and detached stent.The photo was visually reviewed, and it showed that the stent was detached from the balloon.The balloon appeared to still be folded with stent impressions with a lot of bright red blood present at both ends of the balloon cones which appeared to be under the balloon folds.The stent impressions indicate that the stent was crimped on the stent prior to being placed in to the stent protector.As the stent protector was able to be placed on the crimped stent during manufacturing, this indicates that the device was manufactured correctly.With the amount of blood in the balloon cones and the appearance of the device in the photo, it looks like the device came into contact with blood and was not just prepped on the back table.Analysis was concluded based on the received photo of the complaint device.
Event or Problem Description
It was reported that stent dislodgement occurred.During preparation of a 6.0mmx14mmx90cm express sd renal/biliary stent, the physician removed the plastic covering that was on top of the stent and at the same time the stent came with it.The device was replaced with another of the same device to complete the procedure.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: 8943973
• Report Number: 2134265-2019-10297
• Device Sequence Number: 2520957
• Product Code: NIN
• UDI-Device Identifier: 08714729484837
• UDI-Public: 08714729484837
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/10/2019

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: 05/15/2020
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0020649698
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1