MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HYDRA; PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Model Number	SIT-361-100
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
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
Note: this report pertains to two of two devices used in the same procedure.It was reported to boston scientific corporation that hydra irrigation tubing and a water jet connector was used in a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, while hydra irrigation tubing was connected to a hydra water jet connector, backflow of liquid was observed.The procedure was completed using another hydra irrigation tubing and water jet connector.There was no serious injury nor adverse patient effects reported as a result of this event and the patient was reported to be stable.
Additional Manufacturer Narrative
Block h6: device problem code 2588 captures the reportable backflow occurred while using the water jet connector.Block h10: one hydra water jet connector was received for analysis.A visual evaluation of the device found that the inner valve, in the connector, had shifted away from the intended location.No other issues were noted.Based on the condition of the returned device, the device would allow reflux of fluid into tubing.It is possible that the device was subjected to a higher than average pressure condition, during procedure, resulting in the valve shifting above the posts within the welded enclosure.Therefore, the most probable cause for this event is cause traced to component failure.This indicates that the issue is traced to an expected or random component failure without any design or manufacturing issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
Note: this report pertains to two of two devices used in the same procedure.It was reported to boston scientific corporation that hydra irrigation tubing and a water jet connector was used in a colonoscopy procedure performed on (b)(6)2019.According to the complainant, while hydra irrigation tubing was connected to a hydra water jet connector, backflow of liquid was observed.The procedure was completed using another hydra irrigation tubing and water jet connector.There was no serious injury nor adverse patient effects reported as a result of this event and the patient was reported to be stable.

• Brand Name: HYDRA
• Common Device Name: PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9506137
• Report Number: 3005099803-2019-06219
• Device Sequence Number: 1878329
• Product Code: FEQ
• UDI-Device Identifier: 00816849016955
• UDI-Public: 00816849016955
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K161482
• 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): 01/23/2020

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: 09/22/2021
• Device Model Number: SIT-361-100
• Device Catalogue Number: 60271
• Device Lot Number: 0000180914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1