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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred, the target lesion was located in the moderately tortuous and severely calcified lesion.A 7.0mmx19mmx90cm express sd renal/biliary was used, however, during the procedure the stent was placed inside the patient and prior to reaching the lesion the stent came off the shaft/balloon and had to be retrieved with a snare.The procedure was completed with a different device and there were no patient complications reported.
Event or Problem Description
It was reported that stent dislodgement occurred, the target lesion was located in the moderately tortuous and severely calcified lesion.A 7.0mmx19mmx90cm express sd renal/biliary was used, however, during the procedure the stent was placed inside the patient and prior to reaching the lesion the stent came off the shaft/balloon and had to be retrieved with a snare.The procedure was completed with a different device and there were no patient complications reported.
Additional Manufacturer Narrative
E1 - initial reporter first name and last name updated.Device evaluated by mfr.: returned product consisted of an express sd stent with an unknown sheath, 0.014 wire, and a snare.Visual examination revealed that only approximately 7mm of the stent returned and is damaged.Microscopic examination revealed no additional damages.The rest of the stent and the balloon catheter did not return for analysis.Inspection of the remainder of the device presented no damage or irregularities.Product analysis confirmed the stent dislodgement.

• Brand Name: EXPRESS SD RENAL/BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17515264
• Report Number: 2124215-2023-41685
• Device Sequence Number: 8306212
• Product Code: NIN
• UDI-Device Identifier: 08714729390527
• UDI-Public: 08714729390527
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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: 04/27/2025
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0029294576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown