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

Catalog Number 1012274-20

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medical devices: guide catheter: boston scientific 6f cl3.5, dilatation catheters: 3.0 x 20 mm trek, stent: 2.5 x 8 mm xience sierra.(b)(4).The device was not returned for evaluation.Investigation is not yet complete.A follow-up will be submitted with all relevant information.The additional trek rx and xience sierra devices are being filed under separate medwatch reports.

Event Description

It was reported that the procedure was to treat a moderately tortuous, bifurcation lesion in the diagonal and mid left anterior descending (lad) artery with 80% stenosis.The 2.5 x 8 mm xience sierra drug eluting stent was deployed in the lad.Plaque shift occurred closing off the diagonal artery during stent deployment.Kissing balloon technique was performed for post dilatation with two 3.0 x 20 mm trek balloon dilatation catheters (bdc) to open the stent struts of the xience and improve the blood flow in the diagonal.The first 3.0 x 20 trek was advanced to the lad and the second 3.0 x 20 trek was placed in the diagonal artery.Resistance had been met with the guiding catheter during advancement of both treks.Both balloons were inflated to 12 atmospheres and negative pressure was held 4 seconds to deflate the balloons.During removal of the second trek bdc, strong resistance was met as the balloon was only partially deflated.Force was used to remove the bdc and the shaft separated.The decision was made to inflate the other trek balloon to assist in removing the separated trek shaft, but resistance with the guide catheter was also met with this trek.All the devices were removed as a unit.A new guide catheter and balloon catheters were used to complete the procedure.The outcome was not as good as they had hoped because the diagonal vessel became occluded, but the patient is doing well.No additional information was provided.

Event Description

Subsequent to the initial filed medwatch report, a damaged abbott guide wire was returned to abbott vascular.Follow-up with the account confirmed the this guide wire was used with the second 3.0x20 mm trek balloon.There was difficulty removing the trek from the abbott guide wire, so all devices were removed as a unit.The patient is doing well.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: (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 incidents from this lot.It was reported that the trek rx balloon dilatation catheter was used in an attempt to remove the partially deflated separated balloon.It should be noted the coronary dilatation catheters, trek rx, 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 and balloon dilatation of a stent after implantation.In this case, it is unknown if the reported ifu violation caused or contributed to the reported complaint.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The unknown abbott guide wire referenced is filed under separate medwatch manufacturer report number.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7507804
• MDR Text Key: 108161792
• Report Number: 2024168-2018-03501
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 1012274-20
• Device Lot Number: 80131G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10 FOR CONCOMITANT MEDICAL PRODUCTS; UNKNOWN ABBOTT GUIDE WIRE