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

Model Number	M00566670
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 inflation device was opened for a procedure on an unknown date.According to the complainant, it was noted that the device¿s inner plastic blister/tray was broken/cracked.Attempts to obtain additional patient and procedure information have been unsuccessful.If any further relevant information is received, a supplemental mdr will be filed.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Field action # (b)(4).
Event or Problem Description
It was reported to boston scientific corporation that an encore inflation device was opened for a procedure on an unknown date.According to the complainant, it was noted that the device¿s inner plastic blister/tray was broken/cracked.Attempts to obtain additional patient and procedure information have been unsuccessful.If any further relevant information is received, a supplemental mdr will be filed.No patient complications have been reported as a result of this event.

• 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: 6653980
• Report Number: 3005099803-2017-01750
• Device Sequence Number: 1149577
• Product Code: MAV
• UDI-Device Identifier: 08714729755241
• UDI-Public: (01)08714729755241(17)20200331(10)0020456079
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K955869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2017

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: 03/31/2020
• Device Model Number: M00566670
• Device Catalogue Number: 6667
• Device Lot Number: 0020456079
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2017
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 08/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1