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

Model Number SIT-576-15

Device Problem Reflux within Device (1522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

The reported lot number could not be matched to the reported device.Therefore, the lot expiration and device manufacture dates are unknown at this time.(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 Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report #: 3005099803-2018-01610 for the other associated device information.It was reported to boston scientific corporation that a hydra irrigation tubing was used in conjunction with a hydra olympus water jet connector during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2018.According to the complainant, after one procedure, a backflow into the tubing was noted during clean up.The patient's condition at the conclusion of the procedure was reported to be fine.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2018-01610 for the other associated device information.It was reported to boston scientific corporation that a hydra irrigation tubing was used in conjunction with a hydra olympus water jet connector during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2018.According to the complainant, after one procedure, a backflow into the tubing was noted during clean up.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Visual analysis of the returned device found the tubing has no signs of obvious damage.An air-filled syringe was connected to the distal end of the device and air was pushed through at low and high pressures.Air passed through the check valve at high pressure, but not at low pressure.The plastic collar was cut away from the connector using small cutting pliers and pushed off the barb using large cutting pliers as a wedge.A blade was used to help remove the tubing from the barb.The check valve was observed under magnification to detect any misalignment of the white valve inside of the plastic housing or for any signs of debris or damage.A fiber was observed inside the valve area.Although it is difficult to ascertain if the fiber is inside of the valve or between the 2 halves of the housing, it¿s most likely that the fiber was collected during the procedure.A balloon inflation device was connected to the distal end of the check valve to evaluate flow at measurable pressures.At low pressure (starting to push fluid), the fluid would pass through the valve.When the pressure is increased even a little bit flow stops as the check valve closes.Once pressurized, the device could withstand back flow pressure at loads much higher than the requirement of 30 psi.The minimum functional pressure of the valve was evaluated by slowly reducing the pressure until the valve opened.Once open, the fluid begins to flow slightly as the pressure differential is lost.This test indicates that the valve is functional even at low pressures (less than 0.5 atm, or 7psi).The device therefore meets its manufacturing requirements and is not defective.Backflow should only be possible when both the irrigation tubing and the water jet connector valves both fail.However, the water jet connector was not returned for analysis.Therefore, the most probable root cause of this complaint is "undeterminable" since review and analysis of all available information fails to indicate a root cause or probable cause.

• Brand Name: HYDRA
• Type of Device: PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7542442
• MDR Text Key: 109193862
• Report Number: 3005099803-2018-01611
• Device Sequence Number: 1
• Product Code: FEQ
• Combination Product (y/n): N
• PMA/PMN Number: K161482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIT-576-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Date Manufacturer Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1