MAUDE Adverse Event Report: ABBOTT VASCULAR DVI ROTATING HEMOSTATIC VALVE; ACCESSORIES

Model Number 23242

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 09/22/2022

Event Type  malfunction  

Event Description

It was reported that during preparation, when the rotating hemostatic valve (rhv) was flushed, a foreign black object came out from inside the rhv.There was no patient involvement and no clinically significant delay in the procedure.Another device was used to successfully complete the procedure.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was returned for analysis.The reported contamination problem was able 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.As the confirmed loose unknown black material inside the rhv body was lost during return analysis, a positive identification of the contamination could not be performed.It is possible that the reported contamination/noted loose unknown black material inside the body was inadvertently introduced into the rhv during preparation or during use; however this cannot be confirmed.The investigation determined a conclusive cause for the reported/noted contamination problem cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: DVI ROTATING HEMOSTATIC 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: 15592346
• MDR Text Key: 306988968
• Report Number: 2024168-2022-10606
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 08717648013362
• UDI-Public: 08717648013362
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K854261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 23242
• Device Catalogue Number: 23242
• Device Lot Number: 60337170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2021
• 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