MAUDE Adverse Event Report: ABBOTT VASCULAR COPILOT BLEEDBACK CONTROL VALVE; ACCESSORIES

Model Number 1003331

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

User facility medwatch report (b)(4) received that states: the copilot bleedback control valve had blood in the pressure line causing a back-up in the line.Another unspecified device was used.There was no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.It is possible the device was not fully connected/tightened; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.D10, h3: device return status.

• Brand Name: COPILOT BLEEDBACK CONTROL VALVE
• Type of Device: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10532473
• MDR Text Key: 207038701
• Report Number: 2024168-2020-07686
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 08717648013997
• UDI-Public: 08717648013997
• Combination Product (y/n): N
• PMA/PMN Number: K991102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

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 Expiration Date: 01/31/2022
• Device Model Number: 1003331
• Device Catalogue Number: 1003331
• Device Lot Number: 60225167
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 50