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

Model Number	M0067101140
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 unpacked for an angioplasty procedure for the heart artery performed on (b)(6) 2020.According to the complainant, during preparation, it was noticed that there were some liquid inside the tubing.Reportedly, there was no damage noted to the packaging of the device.The procedure was completed with another encore inflation device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: problem code 2944 captures the reportable investigation result of foreign matter.Block h10: investigation results visual examination of the returned complaint device revealed some residues of silicon was found in the inner wall of the barrel; however, there was no problem detected.Media inspection was performed, it was noted that the photo attached looks like there is some type of liquid within the flexcil line but upon product analysis the flexcil line was fine, no liquid.The returned device review (visual, physical, and performance testing) showed no evidence of either the alleged or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that an encore inflation device was unpacked for an angioplasty procedure for the heart artery performed on (b)(6), 2020.According to the complainant, during preparation, it was noticed that there were some liquid inside the tubing.Reportedly, there was no damage noted to the packaging of the device.The procedure was completed with another encore inflation device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

• Brand Name: ENCORE 26
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9957133
• Report Number: 3005099803-2020-01648
• Device Sequence Number: 19481997
• Product Code: MAV
• UDI-Device Identifier: 08714729755814
• UDI-Public: 08714729755814
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

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: 08/19/2022
• Device Model Number: M0067101140
• Device Catalogue Number: 710-114
• Device Lot Number: 0024297079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1