MAUDE Adverse Event Report: AV-TEMECULA-CT COPILOT BLEEDBACK CONTROL VALVE; HEMOSTATIC VALVE

Catalog Number 1003331

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problems Air Embolism (1697); Bradycardia (1751); Cardiac Arrest (1762)

Event Date 03/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported the procedure was performed to treat a lesion in the ostial left anterior descending (lad) and mid circumflex coronary arteries.During the procedure an air embolism occurred.The patients heart rate dropped due to the air embolism and became unresponsive and was starting to code.Cardiopulmonary resuscitation (cpr) was performed and the patient was intubated and pacemaker placed to continue with the procedure.The procedure was completed successfully.Intubation and pacemaker were removed a couple of hours after the procedure.The physician thought that air was introduced via the copilot.Additional information received from the account reported that the copilot upon flushing made a sputtering sound instead of the usual flush of saline.The patient was discharged without any issues.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned for analysis.The reported leak and the reported device operates differently/noise were unable to be confirmed.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 that the devices were not properly aligned while attempting to connect thus resulting in the reported leak and the reported device operates differently/sputtering sound; however this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported leak and the reported noise.Additionally, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: COPILOT BLEEDBACK CONTROL VALVE
• Type of Device: HEMOSTATIC VALVE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7483522
• MDR Text Key: 107250513
• Report Number: 2024168-2018-03258
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 08717648013997
• UDI-Public: 08717648013997
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 1003331
• Device Lot Number: 60105637
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention