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

Model Number SIT-576-15

Device Problem Reflux within Device (1522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/31/2020

Event Type  malfunction  

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 Description

It was reported to boston scientific corporation that hydra irrigation tubing was used in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, backflow of bile was observed.It is unknown how the procedure was completed.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that hydra irrigation tubing was used in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, backflow of bile was observed.It is unknown how the procedure was completed.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: device problem code 2588 captures the reportable event of reflux within device.Block h10: hydra irrigation tubing was received for analysis.A visual evaluation of the returned device found no issues on the tubing.The bottle cap was visually analyzed and no issues were noted.During functional testing, water was injected through the device to check for leaks, and no issues were found.The device was connected to the spyscope ds and water was injected through both device and backflow was not noted.The returned device review did not show evidence of the alleged issue or any defect that could have contributed to the event.Based on all gathered information, the most probable cause of the reported event is no problem detected, which indicates that the device complaint or problem cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.Block h11: correction: block d3 updated (manufacturer name, manufacturer address 1, manufacturer city, manufacturer state, manufacturer zip/postal code, mfr country).

• Brand Name: HYDRA
• Type of Device: PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; jintan area; marlborough MA 01752
• MDR Report Key: 10581770
• MDR Text Key: 208386731
• Report Number: 3005099803-2020-04162
• Device Sequence Number: 1
• Product Code: FEQ
• UDI-Device Identifier: 00840253108401
• UDI-Public: 00840253108401
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2023
• Device Model Number: SIT-576-15
• Device Catalogue Number: SIT-576-15
• Device Lot Number: 0000200405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1