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

Model Number 1003331

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 08/18/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a neurological lesion in the brain.During a procedure, the doctor used the hemostatic valve, which did not allow hemostasis because it did not close properly.This situation occurred with two valves from the same lot.There was no adverse patient effects and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

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.The additional copilot device referenced in this report is filed under a separate medwatch report number.

Manufacturer Narrative

The device was returned for analysis.The reported loose or intermittent connection was 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 difficulties were unable to be confirmed during return analysis, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the device was not fully connected/tightened resulting in the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• 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: 15382398
• MDR Text Key: 305691005
• Report Number: 2024168-2022-09498
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 08717648013997
• UDI-Public: 08717648013997
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Report Date: 11/08/2022

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 Expiration Date: 03/31/2024
• Device Model Number: 1003331
• Device Catalogue Number: 1003331
• Device Lot Number: 60362233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 11/08/2022
• Supplement Dates FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2022
• 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