MAUDE Adverse Event Report: ABBOTT VASCULAR 20/30 PRIORITY PACK INDEFLATOR; ACCESSORIES

Catalog Number 1000184

Device Problems Leak/Splash (1354); Obstruction of Flow (2423)

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

Event Date 06/23/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Na.

Event Description

It was reported that the procedure was to treat an unspecified lesion.An indeflator 20/30 ppak was pulling in air when negative was pulled, and the tube end of the indeflator was occluded.There were no reported adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported leak and the reported obstruction of flow/tube occlusion 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 identified no other incidents from this lot.As the reported difficulties were unable to be confirmed during return analysis, it is possible that the connection port was not fully connected/tightened thus resulting in the reported leak; however this cannot be confirmed.The reported obstruction of flow/tube occlusion was unable to be confirmed.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: 20/30 PRIORITY PACK INDEFLATOR
• 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: 17435717
• MDR Text Key: 320410012
• Report Number: 2024168-2023-08301
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08717648013591
• UDI-Public: 08717648013591
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K961471
• 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: 08/24/2023

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: 01/31/2024
• Device Catalogue Number: 1000184
• Device Lot Number: 60418052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 08/21/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2022
• 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