MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHDOGTM HEMOSTASIS VALVE KIT

Model Number 161

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2022

Event Type  malfunction  

Event Description

It was reported that the device was contaminated.Small microscopic pieces of foreign material were observed on a napkin when the watchdog hemostasis valve used along with an introducer needle.No patient harm resulted in relation to this event.

Manufacturer Narrative

Device technical analysis: the device was not returned to the complaint investigation site (cis) for analysis as it was reportedly disposed at the facility.Photo media was provided depicting black residue on a white surface.No device was depicted in photo.

Event Description

It was reported that the device was contaminated.Small microscopic pieces of foreign material were observed on a napkin when the watchdog hemostasis valve used along with an introducer needle.No patient harm resulted in relation to this event.

• Brand Name: WATCHDOGTM HEMOSTASIS VALVE KIT
• Type of Device: HEMOSTASIS VALVE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC LIMITED; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15259801
• MDR Text Key: 300174546
• Report Number: 2124215-2022-31532
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K172453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2022

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
• Device Operator: Health Professional
• Device Model Number: 161
• Device Catalogue Number: 161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 08/19/2022
• Supplement Dates Manufacturer Received: 09/15/2022
• Supplement Dates FDA Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1