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

Model Number	1012272-25
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Codes	Air Embolism (1697); Cardiac Arrest (1762); Occlusion (1984)
Date of Event	03/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a mildly tortuous and restenosed lesion in the circumflex artery.The patient presented with non-st segment elevation myocardial infraction.A 2.5x25mm trek rx balloon dilatation catheter (bdc) was prepared per normal procedure.The bdc was advanced to the target lesion; however, the balloon did not inflate.The bdc was removed to access the issue.At this point, the patients pressure began dropping rapidly.Another angio was taken and it was noticed that the left marginal artery became occluded.The patient arrested.More heparin was given and the patient was recovered using cardiopulmonary resuscitation.Flow was restored and the procedure was quickly completed.Following the procedure, the bdc was investigated and it is believed that there may have been a slow leak, which collected atmospheric air upon preparation, which subsequently caused an air embolism.The bdc was tested under water and a leak on the shaft was noted.There were no adverse patient sequela and a clinically significant delay in the procedure was reported.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.As there was no report of a leak during preparation (air aspiration) prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement interaction of devices/anatomy and/or manipulation of the device resulted in compromising the device; thus resulting in the reported shaft leak and the reported inflation problem.The reported patient effects of embolism and occlusion are listed in the trek rx coronary dilatation catheter instructions for use as known patient effects of coronary procedures.The reported difficulties possibly caused/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(s) 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.D10, h3 - it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.

• Brand Name: TREK RX CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9978396
• Report Number: 2024168-2020-03758
• Device Sequence Number: 14062738
• Product Code: LOX
• UDI-Device Identifier: 08717648138317
• UDI-Public: 08717648138317
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 1012272-25
• Device Catalogue Number: 1012272-25
• Device Lot Number: 91129G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 46 YR