MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK WATCHDOGTM HEMOSTASIS VALVE

Model Number H74939343021

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolism (1829); Discomfort (2330)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that an air embolism occurred.The target lesion was located in the saphenous vein.A watchdog tm hemostasis valve was in use and the physician noticed air was pulling into the syringe during "act" draws.The manifold system was hooked up to the device.Later during the case while they had in a guidewire and a balloon, they observed a large air embolus injected into the saphenous vein graft they were working in.The physician felt the watchdog was responsible for the air in the system; that the valve possibly failed to create a seal allowing air to pass through which cause air to be injected into the coronary artery.They immediately switched to a non bsc bleed-back control valve and no further air was observed.The patient was not harmed and had no electrocardiogram changes as a result of the air injection.The patient stated they had a funny feeling in their neck.The patient is in stable condition.

Manufacturer Narrative

Device evaluated by mfr: the returned product consisted of a watchman hemostasis valve in the unlocked position.Based on the potential root causes identified in the fmea, the seals, plunger, luer and port were microscopically and visually inspected.Inspection of the device presented no damage or irregularities.Since the devices used in the clinical event were not returned for analysis, a test mach1 guide catheter, a balloon catheter and wire were used for functional testing.The mach 1 was attached to the watchdog, then a balloon catheter with a wire was inserted into the watchdog and guide catheter.The end of the mach 1 with the balloon and wire was placed in a glass of water, then a syringe full of water was hooked up to the side port.The syringe was pulled and pushed and there were no air leaks when the distal seal is locked.The distal seal was unlocked and tested again and air does go into the syringe when the distal seal is unlocked.The investigation conclusion is user/use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.The watchdog directions for use includes the following instruction: if required to draw a blood sample attach a syringe to the manifold system or side port of the watchdog hemostasis valve and withdraw the blood.Before withdrawing blood, always close the distal seal by rotating the plunger in clockwise direction.(b)(4).

Event Description

It was reported that an air embolism occurred.The target lesion was located in the saphenous vein.A watchdogtm hemostasis valve was in use and the physician noticed air was pulling into the syringe during "act" draws.The manifold system was hooked up to the device.Later during the case while they had in a guidewire and a balloon, they observed a large air embolus injected into the saphenous vein graft they were working in.The physician felt the watchdog was responsible for the air in the system; that the valve possibly failed to create a seal allowing air to pass through which cause air to be injected into the coronary artery.They immediately switched to a non bsc bleed-back control valve and no further air was observed.The patient was not harmed and had no electrocardiogram changes as a result of the air injection.The patient stated they had a funny feeling in their neck.The patient is in stable condition.

• Brand Name: WATCHDOGTM HEMOSTASIS VALVE
• Type of Device: HEMOSTASIS VALVE
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• MDR Report Key: 7367538
• MDR Text Key: 103398219
• Report Number: 2134265-2018-02203
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2018
• Device Model Number: H74939343021
• Device Lot Number: 21146746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Date Manufacturer Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR