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

Catalog Number 1003327

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 01/04/2024

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 indeflator device was attempted to be used in procedure to inflate a balloon; however, a leak was noted at the connection point.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported leak and the reported loose or intermittent connection were unable to be confirmed.A proxy balloon dilatation catheter was connected to the rotator end of the indeflator and formed a secure connection with no anomalies noted.Device history record (dhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.As the reported difficulties were unable to be confirmed during return analysis, it is possible that the devices were not properly aligned and/or not fully connected/tightened while attempting to connect and/or the port of the device being connected was compromised resulting in the reported loose/intermittent connection and ultimately resulting in the reported leak; however this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported difficulties.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 18752701
• MDR Text Key: 336190684
• Report Number: 2024168-2024-02183
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08717648013973
• UDI-Public: (01)08717648013973(17)250930(10)60504322
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

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: 1003327
• Device Lot Number: 60504322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2023
• 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