MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ENCORE¿ 26; SYRINGE, BALLOON INFLATION

Model Number	M0067101131
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
This report pertains to one of two devices used during the same procedure.Manufacturer report # 3005099803-2017-01612 pertains to the first encore inflation device and manufacturer report # 3005099803-2017-01613 pertains to the second encore inflation device.It was reported to boston scientific corporation that two encore inflation devices were used in the superior femoral artery during an angiogram of the leg procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the gauge of the device would not show any pressure and the gauge needle did not move at all.It was also noticed that the threaded plunger would not lock and seemed to be loose.The same event occurred with the second inflation device.The procedure was completed with another encore inflation device.There were no patient complications reported as a result of the event.The patient¿s condition at the conclusion of the procedure was reported to be fine.

• Brand Name: ENCORE¿ 26
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• MDR Report Key: 6577534
• Report Number: 3005099803-2017-01612
• Device Sequence Number: 10937452
• Product Code: MAV
• UDI-Device Identifier: 08714729761815
• UDI-Public: (01)08714729761815(17)20200131(10)0020149003
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2017

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: 01/31/2020
• Device Model Number: M0067101131
• Device Catalogue Number: 710-113
• Device Lot Number: 0020149003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1