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

Model Number 1003327

Device Problem Leak/Splash (1354)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/13/2022

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that before the intervention, heparin, aspirin and plavix were administered.The indeflator was connected to a balloon catheter in the coronary artery.During inflation attempts, the device was turning freely and did not inflate the balloon.The process was repeated, and air bubbles were visible in the syringe of the indeflator.The indeflator issue resulted in a delay in procedure, and due to the extended presence of the balloon in the coronary artery, a new thrombus was noted in the coronary artery.When the thrombosis was detected, it was aspirated and treated with agrastat.The patient condition remained good.There was no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis; however, this complaint appears to be related to a manufacturing issue associated with leak issues.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.One nonconforming material record/exception was generated for the finished good lot to investigate the reported issue in accordance with internal operating procedures.The reported patient effect of thrombosis is not listed in the 20/20 (20/30) priority pack with copilot bleedback control valve, global, instructions for use (ifu) as a known patient effect of coronary procedures, however thrombosis is listed as foreseeable event in the no-fault errors for coronary and endovascular products risk assessment (ram).A medical review was performed by an abbott vascular clinical specialist: this was a case to treat a stenosis, in an unreported coronary artery, in a patient of an unknown age and gender.It was reported that during several attempts to inflate an unknown balloon dilatation catheter (bdc), the indeflator handle rotated freely and the balloon did not inflate.Air bubbles were reportedly seen when the indeflator was pulled to negative pressure.Due to the reported extended time of the procedure and the failure to remove the unknown bdc from the coronary artery while attempting to troubleshoot the indeflator or replace the indeflator, the coronary artery developed an acute thrombosis, which was successfully treated with an unknown aspiration catheter and the anticoagulation medication aggrastat.The patient is reportedly doing well post procedure.The ppak 20/30 indeflator is an entirely outside the body device.Meaning that the device does not come in contact with the patient¿s skin, nor does it come in direct contact with the blood vessels.Therefore, it is incapable of directly causing an acute thrombosis in any blood vessel.Due to the prolonged procedure, the lack of complete procedural information or the patient¿s past medical history, it can be definitively stated that the ppak 20/30 w/co-pilot was not a direct cause of the acute thrombosis in this patient.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.The investigation determined the reported leak appears to be a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.On february 25th, 2022, abbott vascular determined that a field safety corrective action is required for specific lots of 20/30 and plus 30 indeflators and associated priority packs: 20/30 priority pack with copliot, 20/30 priority pack, priority pack 20/30 w/115 rhv, ppak 20/30 with rhv, plus 30, ppakplus30, ppakplus30 w/115 rhv.This action is being taken due to an increase in the complaint trend for reported device code leak/splash, and loose or intermittent connection.20/30 indeflators are at an increased risk of leaking due to a gap in the hose snap fitting.Stopcocks are at an increased risk of leaking due to a higher tendency for loose connections when not connected properly.

• 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: 13472422
• MDR Text Key: 285182082
• Report Number: 2024168-2022-01228
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08717648013973
• UDI-Public: 08717648013973
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 1003327
• Device Catalogue Number: 1003327
• Device Lot Number: 60323317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/07/2022
• Supplement Dates Manufacturer Received: 02/25/2022
• Supplement Dates FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: UNK
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention