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

Model Number	M00566670
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 used during an esophageal dilation procedure performed on (b)(6) 2019.According to the complainant, during procedure, the balloon was able to be inflated as observed on fluoroscopy; however, the manometer did not move.The procedure was completed with another encore inflation device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Problem code 1184 captures the reportable issue of reading inaccurate.A visual examination of the complaint device revealed that the device does not have visual defects.The gauge needle was at 0 atm.Functional evaluation was performed and was unable to confirm that the gauge was reading inaccurately.It was noted that the device was able to be inflated properly.The returned device passes visual and functional tests, consequently, not confirming the reported complaint.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 used during an esophageal dilation procedure performed on (b)(6) 2019.According to the complainant, during procedure, the balloon was able to be inflated as observed on fluoroscopy; however, the manometer did not move.The procedure was completed with another encore inflation device.There were no patient complications reported as a result of this event.

• 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: 8354476
• Report Number: 3005099803-2019-00838
• Device Sequence Number: 16693955
• Product Code: MAV
• UDI-Device Identifier: 08714729755241
• UDI-Public: 08714729755241
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/21/2019

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: 10/22/2021
• Device Model Number: M00566670
• Device Catalogue Number: 6667
• Device Lot Number: 22833633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1