MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENCORE 26; SYRINGE, BALLOON INFLATION, EXEMPT

Model Number	M0067101140
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Percutaneous nephrolithotomy attempted.Upon inflating nephrostomy balloon catheter filled with contrast, balloon ruptured while in the patient.This caused contrast to spill which prevented continuing with the case due to poor visualization.Case aborted by the surgeon.

• Brand Name: ENCORE 26
• Common Device Name: SYRINGE, BALLOON INFLATION, EXEMPT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10626432
• Report Number: 10626432
• Device Sequence Number: 16802137
• Product Code: PTM
• UDI-Device Identifier: 08714729755814
• UDI-Public: (01)08714729755814
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/09/2020
• Report Date (Section F): 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0067101140
• Device Lot Number: 25522830
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/09/2020