MAUDE Adverse Event Report: ABBOTT VASCULAR MINI TREK RX OTW LIMITED INDICATION; CORONARY DILATATION CATHETER

Catalog Number	1012403-20A
Medical Device Problem Codes	Inflation Problem (1310); Off-Label Use (1494)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Exemption number: e2019001.
Event or Problem Description
It was reported that the procedure was performed to treat a non-tortuous, non-calcified, proximal peroneal lesion.The device was reported to be used off label.The 2.0x20mm otw mini trek ii balloon dilatation catheter (bdc) was advanced to the target lesion but the balloon would not inflate at all.A new unspecified device was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Device analysis noted a tear of the inner member in the hub.
Additional Manufacturer Narrative
Visual, functional and sem inspections/analysis were performed on the returned device which identified a tear in the inner member of the hub.The reported inflation issue was confirmed.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/complaints from this lot.It should be noted the coronary dilatation catheters (cdc), mini trek ii over the wire (otw), global, instructions for use (ifu) states: the mini trek ii otw coronary dilatation catheter is 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 (mi), balloon dilatation of a stent after implantation (balloon models 2.00 mm only) and balloon dilatation of de novo chronic total coronary occlusions (cto).The investigation determined the reported inflation issue appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: MINI TREK RX OTW LIMITED INDICATION
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9158482
• Report Number: 2024168-2019-12374
• Device Sequence Number: 2430288
• Product Code: LOX
• UDI-Device Identifier: 08717648180897
• UDI-Public: 08717648180897
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 1012403-20A
• Device Lot Number: 90219G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR