MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE; SYRINGE, BALLOON INFLATION

Model Number	M0067101140
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an encore 26 inflation device was unpacked for a percutaneous nephrolithotomy (pcnl) procedure on (b)(6) 2017.According to the complainant, during preparation, they noticed that the device's inner tray was cracked.They opened another encore 26 inflation device to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• MDR Report Key: 6613173
• Report Number: 3005099803-2017-01579
• Device Sequence Number: 10886334
• Product Code: MAV
• UDI-Device Identifier: 08714729755814
• UDI-Public: (01)08714729755814(17)20200229(10)0020336387
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K955869
• 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
• Report Date (Section B): 05/12/2017

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: 02/29/2020
• Device Model Number: M0067101140
• Device Catalogue Number: 710-114
• Device Lot Number: 0020336387
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2017
• Initial Report FDA Received Date: 06/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1