MAUDE Adverse Event Report: AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER

Catalog Number	1012278-20
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Codes	Air Embolism (1697); Transient Ischemic Attack (2109)
Date of Event	02/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for evaluation.It should be noted that the instructions for use (ifu) states: trek rx coronary dilatation catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion, balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction.In this case, it is unknown if the reported ifu violation caused or contributed to the reported complaints.The reported patient effect of air embolism is listed in the trek rx ifu, as a known patient effect.The investigation was unable to determine a conclusive cause for the reported balloon rupture; however, the reported patient effects of air embolism and transient ischemic attack appear to be related to circumstances of the procedure.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 similar incidents from this lot.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the carotid artery with no calcification.The 4.0x20 mm trek rx balloon dilatation catheter (bdc) ruptured at 12 atmospheres and released some air.The patient experienced stroke like symptoms [transient ischemic attack] for about 30 minutes and then they resolved with no residual effects.No treatment was administered during the 30 minutes of symptoms.The procedure was completed with an additional balloon.There was a clinically significant delay in the procedure due to the adverse symptoms caused by the air embolism.No additional information was provided.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8363311
• Report Number: 2024168-2019-01361
• Device Sequence Number: 1833466
• Product Code: LOX
• UDI-Device Identifier: 08717648138720
• UDI-Public: 08717648138720
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

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: 01/31/2021
• Device Catalogue Number: 1012278-20
• Device Lot Number: 80219G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 02/22/2019
• 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: Other