MAUDE Adverse Event Report: ABBOTT VASCULAR MINI TREK CORONARY DILATATION CATHETER

Model Number 1012270-20

Device Problems Inflation Problem (1310); Material Rupture (1546)

Patient Problems Air Embolism (1697); Angina (1710); Non specific EKG/ECG Changes (1817)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a proximal left anterior descending artery.A 2x20mm mini trek balloon was prepared according to routine.The balloon was inflated once to 12 atmospheres and only partially inflated but was noted to be losing pressure.During this it was noted that the patient then developed severe chest pain for approximately 10 minutes.Simultaneously, st elevation was also noted.During an x-ray several micro-bubbles of air were noted entering the coronary vessel which was confirmed to be an air embolism.It was noted that the air embolism ultimately disappeared and was not treated.The chest pain and st elevation was treated via medication.The balloon was removed and after control inflation, leakage was noted from coming from the balloon itself.The patient felt discomfort for approximately 10 minutes, but ultimately felt recovered after the procedure.Although the procedure was prolonged for about 5 minutes, there was no patient injury or clinically significant delay noted.Another device was used to successfully complete the procedure.No additional information was provided.

Manufacturer Narrative

Visual, functional and sem inspections/analysis were performed on the returned device.The reported balloon rupture and inflation issue were confirmed.A review of the lot history record identified one manufacturing nonconformity issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The reported patient effects of air embolism and angina are listed in the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instructions for use as known patient effects.The balloon was ultimately sent to the scanning electron microscopy (sem) lab for further analysis.The sem report determined the balloon and inner member failure may be attributed to mechanical damage to the outer surface.The leak and adjacent area appeared pinched.The investigation determined the reported balloon rupture and inflation issue appear to be related to a potential product quality issue.A conclusive cause for the reported patient effects of air embolism, angina and ekg/ecg changes and the relationship to the device, if any, cannot be determined; however, the reported treatment with medication appears to be related to operational context.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: MINI TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10871500
• MDR Text Key: 217293534
• Report Number: 2024168-2020-09765
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138164
• UDI-Public: 08717648138164
• Combination Product (y/n): N
• PMA/PMN Number: K103110
• 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: 02/09/2021

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 Expiration Date: 12/31/2022
• Device Model Number: 1012270-20
• Device Catalogue Number: 1012270-20
• Device Lot Number: 00122G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention