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

Catalog Number UNKNOWN COPILOT BBC

Device Problem Leak/Splash (1354)

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

Event Date 10/20/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion in the popliteal artery.The co-pilot bleedback control valve was used in a the procedure with a jeti thombectomy device.The thrombectomy device was noted low pressure error code due to a leak in the co-pilot valve.There was no adverse patient effect and no clinically significant delay reported in the procedure.The co-pilot was replaced to continue the procedure.No additional information was provided.

Manufacturer Narrative

The unique device identifier (udi) is unknown because the part number and lot number were not provided.The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the part and lot number was not provided.It is possible that the connections and/or seal was not entirely closed/fully tightened; thus, resulting in the reported leak; however, as the device was not returned for analysis 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.

• 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: 15788689
• MDR Text Key: 303573055
• Report Number: 2024168-2022-11538
• Device Sequence Number: 1
• Product Code: DTL
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2022

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 Catalogue Number: UNKNOWN COPILOT BBC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 91 KG