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

Catalog Number	1012269-20
Medical Device Problem Codes	Inflation Problem (1310); Off-Label Use (1494); Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.(b)(4).The device was not returned for evaluation.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.It was reported that the device was used in the anterior tibial artery.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instructions for use (ifu) states: the mini 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, balloon dilatation of a stent after implantation (balloon models 2.00 mm only) and balloon dilatation of de novo chronic total coronary occlusions (cto).In this case, it is unknown if the ifu violation caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported kink or hole/tear in the shaft and subsequently the inflation issue.Since the device was not returned for analysis, a conclusive cause for the reported complaints could not be determined.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 de novo lesion in a mildly calcified and moderately tortuous anterior tibial artery that was 100% stenosed.A 1.5 x 20 mm mini trek balloon catheter was used; however, the distal shaft where the inner/outer member are became kinked which caused a hole in that area.Therefore, the device was unable to inflate as contrast was leaking from the hole.A 2.0 x 40 mm armada 14 balloon catheter was then 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.

• 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: 9274887
• Report Number: 2024168-2019-13185
• Device Sequence Number: 10799568
• Product Code: LOX
• UDI-Device Identifier: 08717648138119
• UDI-Public: 08717648138119
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Report Date (Section B): 11/04/2019

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: 05/31/2022
• Device Catalogue Number: 1012269-20
• Device Lot Number: 90625G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1