MAUDE Adverse Event Report: ABBOTT VASCULAR 20/30 PRIORITY PACK ACCESSORY KIT; ACCESSORIES

Model Number 1000186-115

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Estimated dates.The device location was not provided, and it is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that during use there was leaking from the rotating hemostatic valve (rhv), causing loss of pressure tracing with other devices.A non-abbott rhv was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

B3: estimated date.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.It is possible the device was not fully connected/tightened; however as the device was not returned for analysis this cannot be confirmed.The investigation determined a conclusive cause for the reported leak cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: 20/30 PRIORITY PACK ACCESSORY KIT
• Type of Device: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11049745
• MDR Text Key: 241254040
• Report Number: 2024168-2020-10786
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08717648015274
• UDI-Public: 08717648015274
• Combination Product (y/n): N
• PMA/PMN Number: K961471
• 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: 01/18/2021

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: 1000186-115
• Device Catalogue Number: 1000186-115
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1