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

Model Number 1003327

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Vascular Dissection (3160)

Event Date 03/02/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat in-stent re-stenosis of the right coronary artery (rca).An indeflator 20/30 was prepped prior to use without issue.The indeflator was then attached to a non-abbott balloon.Negative was pulled and a small amount of air was noted in the balloon.When put on neutral the gauge showed at least 5 cc of air.On attempting to inflate the balloon, slowness in inflation was noted.Numerous turns of the indeflator handle were required to increase the pressure.A ¿silent¿ balloon rupture was ultimately suspected; however, was not immediately detected due to the slow inflation and further pressure was applied.This led to air and contrast from the balloon to enter the rca, leading to a heart block, dye hang up, dissection and the initiation of cardiopulmonary resuscitation (cpr).A delay in the procedure occurred and the patient had to be admitted to critical care for monitoring and further tests.The patient was discharged two days later.No additional information was provided.

Manufacturer Narrative

Device code 2017 - incorrect prep.The device was not returned for analysis.A review of the lot history record and similar incident query of the reported lot could not be conducted because the lot number was not provided.It should be noted that the 20/20 (20/30) priority pack with copilot bleedback control valve, global instructions for use states: aspirate contrast medium by slowly withdrawing the plunger.Evacuate air in the 20/30 indeflator inflation device by slowly injecting the necessary volume from the 20/30 indeflator inflation device back into the syringe.Repeat until all the air is removed from the 20/30 indeflator inflation device and 6 cc of contrast remains.The reported patient effects of air embolism, cardiac arrest and dissection are not listed in the 20/20 (20/30) priority pack with copilot bleedback control valve, global, instructions for use as known patient effects of coronary procedures, however air embolism, cardiac arrest and dissection are listed as foreseeable events.The investigation determined the reported difficulties appear to be related to a deviation of the instructions for use and subsequent circumstances of the procedure as it is likely that the reported small amount of air noted in the balloon and the 5 cc of air in the indeflator was not properly removed from the system/indeflator before an attempt was made to inflate the balloon; thus resulting in the reported leak/slowness in inflation.This resulted in the reported several turns of the indeflator handle being required to increase the pressure.Due to the slow inflation of the indeflator device, the operator continued to turn the handle to apply further pressure to the balloon.This resulted in the silent balloon rupture which was not immediately detected.The reported difficulties possibly contributed to the reported patient effects; however a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was performed to treat in-stent re-stenosis of the right coronary artery (rca).An indeflator 20/30 was prepped prior to use without issue.The indeflator was then attached to a non-abbott balloon.Negative was pulled and a small amount of air was noted in the balloon.When put on neutral the gauge showed at least 5 cc of air.On attempting to inflate the balloon, slowness in inflation was noted.Numerous turns of the indeflator handle were required to increase the pressure.A ¿silent¿ balloon rupture was ultimately suspected; however, was not immediately detected due to the slow inflation and further pressure was applied.This led to air and contrast from the balloon to enter the rca, leading to a heart block, dye hang up, dissection and the initiation of cardiopulmonary resuscitation (cpr).A delay in the procedure occurred and the patient had to be admitted to critical care for monitoring and further tests.The patient was discharged two days later.No additional information was provided.Subsequent to the initially filed mdr, additional information was received noting: the indeflator was prepped with no air in the system, then hooked up to the balloon, and pulled negative and locked.The indeflator was in neutral position prior to connecting the balloon to the indeflator device.Fluoroscopy was performed to confirm the leaking contrast from the balloon.No additional information was provided.

• Brand Name: 20/30 PRIORITY PACK INDEFLATOR
• Type of Device: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11563740
• MDR Text Key: 242066228
• Report Number: 2024168-2021-02348
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08717648013973
• UDI-Public: 08717648013973
• Combination Product (y/n): N
• PMA/PMN Number: K961471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/24/2021

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 Model Number: 1003327
• Device Catalogue Number: 1003327
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2021
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 05/07/2021
• Supplement Dates FDA Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON ABBOTT BALLOON.; NON ABBOTT BALLOON
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR