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

Catalog Number UNK RHV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event ¿ estimated.The unique device identifier (udi) is unknown because the part number and lot number were not provided.The devices were not returned for analysis.Review of the lot history records and similar incident review could not be conducted because the part and lot numbers were not provided.Due to the limited information available, the investigation determined a conclusive cause for the reported patient effect, 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.The other reportable events referenced in the pmcf are filed under separate medwatch report numbers.

Event Description

This is filed to report the potential serious injuries related to the rotating hemostatic valve (rhv).It was reported through the post-market clinical follow-up evaluation (pmcf) report, that the rotating hemostatic valve (rhv) may be related to the adverse patient effects of air embolism and the device malfunctions of leak, loose connection and break.Details are listed in the attached pmcf, titled post-market clinical follow-up evaluation report accessories and indeflators.

• 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: 15195339
• MDR Text Key: 297555223
• Report Number: 2024168-2022-08659
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K854261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK RHV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2022
• 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 Outcome(s): Other