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

Catalog Number 1003331

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional copilot devices referenced in b5 are filed under separate medwatch report numbers.

Event Description

It was reported that the procedure was to treat a lesion in an unspecified artery.The indeflator was attempted to be used, however, a failure with the device valve was reported resulting in blood leakage.Three other indeflators from the same lot had the same issue of blood leakage.Another indeflator with a different lot was used to complete the procedure.There was no reported adverse patient effect and there was no reported 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 did not indicate a lot specific quality issue.It is possible that the devices were not properly aligned and/or not fully connected/tightened while attempting to connect and/or the port of the device being connected was compromised resulting in the reported loose/intermittent connection and ultimately resulting in the reported leak; however, as the device was not returned for analysis this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported loose/intermittent connection and the reported leak.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9, h3 - device returning status updated from unknown to no - retained by hospital.

Event Description

It was reported that the procedure was to treat a lesion in an unspecified artery.The indeflator was attempted to be used, however, a failure with the device valve was reported resulting in blood leakage.Three other indeflators from the same lot had the same issue of blood leakage.Another indeflator with a different lot was used to complete the procedure.There was no reported adverse patient effect and there was no reported clinically significant delay in the procedure.Subsequent to the initially filed reports, the following information was provided: the complaint device is a copilot and the device could not maintain the attachment due to loose connection with an unknown device.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

Event Description

It was reported that the procedure was to treat a lesion in an unspecified artery.The indeflator was attempted to be used, however, a failure with the device valve was reported resulting in blood leakage.Three other indeflators from the same lot had the same issue of blood leakage.Another indeflator with a different lot was used to complete the procedure.There was no reported adverse patient effect and there was no reported clinically significant delay in the procedure.Subsequent to the initially filed reports, the following information was provided: the complaint device is a copilot and the device could not maintain the attachment due to loose connection with an unknown device.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported loose/intermittent connection and the reported leak 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 did not indicate a lot specific quality issue.As the reported leak was unable to be confirmed during returned device analysis, it is possible that the devices were not properly aligned and/or not fully connected/tightened while attempting to connect and/or the port of the device being connected was compromised resulting in the reported loose/intermittent connection and ultimately resulting in the reported leak; however, this cannot be confirmed.40 sterile/unused units were returned from the account (part #1003331 lot #60459943).13 out of the 40 returned sterile/unused devices were visually inspected with no anomalies noted.Functional testing was successfully performed on the 13 sterile/unused devices with no observations or anomalies noted.Potential factors which could contribute to a leak include, but are not limited to, manufacturing, mishandling, damage, loose connections or procedural technique.Factors that could contribute to connection issues include, but are not limited to, damage to the luer of the device, damage to the luer of the device being connected, or user technique/incorrect alignment of the devices.The product risk assessment identifies this as a foreseeable event; as such, design and manufacturing controls and mitigations have been established for potential causes.The investigation was unable to determine a conclusive cause for the reported loose/intermittent connection and the reported leak.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6 correction: medical device problem code 1354 added.H6 correction: type of investigation code 4114 removed; 10 added.H6 correction: investigation findings code 213 removed; 114 added.

• Brand Name: COPILOT® BLEEDBACK CONTROL VALVE
• Type of Device: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18476535
• MDR Text Key: 332611269
• Report Number: 2024168-2024-00431
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 08717648013997
• UDI-Public: (01)08717648013997(17)250430(10)60459943
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K991102
• 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,Followup
• Report Date: 05/20/2024

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 Catalogue Number: 1003331
• Device Lot Number: 60459943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 01/26/2024; 04/29/2024
• Supplement Dates FDA Received: 02/19/2024; 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2023
• 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