MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Catalog Number 1012272-30

Device Problem Off-Label Use (1494)

Patient Problem Perforation of Vessels (2135)

Event Date 07/07/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device location was not provided and it is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.The udi is unknown as the part/lot numbers were not provided.

Event Description

It was reported that on (b)(6) 2021, the patient presented for a percutaneous peripheral intervention.A non-abbott stent was implanted in the distal superficial femoral artery, reducing stenosis.Angioplasty was then performed on the left anterior tibial (at) artery using a 2.5x30mm trek balloon catheter.The at stenosis was reduced from 80% to 30% with good results, however a mid-left at perforation was observed.Balloon angioplasty was performed; however, it was not successful at sealing the perforation.A 2.8x26mm graftmaster stent was then implanted mid-distal at, without a device issue reported, sealing the perforation.Reportedly, hemostasis was achieved.No additional information was provided regarding this issue.

Manufacturer Narrative

Product performance engineering reviewed the incident information; however, there was no reported device malfunction and the product was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It was reported that the procedure was to treat a superficial femoral artery.It should be noted the coronary dilatation catheters trek rx and mini trek rx, global, instruction for use (ifu) 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, balloon dilatation of a stent after implantation.In this case, it is unknown if the ifu violation contributed to the reported perforation.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined; however, the reported ifu violation (incorrect anatomy) appears to be related to user error.Additionally, additional treatment appears to be related to operational context of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12212028
• MDR Text Key: 262955792
• Report Number: 2024168-2021-06357
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 1012272-30
• Device Lot Number: 10112G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6 FRENCH MB1 GUIDE CATHETER; ZILVER STENT; 6 FRENCH MB1 GUIDE CATHETER; ZILVER STENT
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 58