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

Catalog Number	1012278-20
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Incorrect anatomy.The device was not returned for evaluation.It should be noted that the instructions for use states: the 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 and balloon dilatation of a stent after implantation.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported difficulty positioning and removing the guide wire; however, the reported separation appears to be related to operational context due to the reported difficulty removing the balloon catheter from the guide wire.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 the procedure was performed in the internal carotid.A 4.0 x 20 mm trek balloon catheter could not advance over the guide wire, and strong resistance was felt during withdrawal of the device.The balloon catheter was removed but the part of the distal shaft (including the balloon) had separated and remained inside the patient.The distal shaft was surgically removed during removal of a carotid stent in the internal artery.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Additional information received indicating that two non-abbott carotid stents were implanted during the procedure and both were removed surgically.

• 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: 7109172
• Report Number: 2024168-2017-09620
• Device Sequence Number: 13726097
• Product Code: LOX
• UDI-Device Identifier: 08717648138720
• UDI-Public: 08717648138720
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2018

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 Catalogue Number: 1012278-20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: 8 FR.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention