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

Catalog Number 1000186

Device Problem Leak/Splash (1354)

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

Event Date 03/19/2024

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.The device history record 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.It is possible that the connection port was not fully connected/tightened and/or the device being connected was compromised thus resulting in the reported leak difficulties; however as the device was not returned for analysis this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported leak 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.

Event Description

It was reported that during a procedure was to treat the right coronary artery.The indeflator failed to inflate the balloon when applying pressure.Another indeflator was used to successfully complete the procedure.There was no adverse patient effects reported and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

H6: health effect - impact code 4648 removed and 2199 added.

• Brand Name: 20/30 PRIORITY PACK ACCESSORY KIT
• 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: 19068044
• MDR Text Key: 339775639
• Report Number: 2024168-2024-04437
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08717648013614
• UDI-Public: (01)08717648013614(17)250930(10)60511562
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 04/11/2024

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: 1000186
• Device Lot Number: 60511562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2023
• 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