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

Catalog Number 1012278-20

Device Problems Detachment Of Device Component (1104); Deflation Problem (1149)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/01/2016

Event Type  Injury  

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.

Event Description

It was reported that the procedure was to treat an arterio-veinous (av) fistula in the left arm.A 4x20mm trek rx balloon dilatation catheter (bdc) stylet/protective sheath was removed without resistance.The hub was filled and the bdc was flushed and aspirated outside the anatomy prior to use.The trek was advanced without resistance toward the av fistula.The balloon was inflated three times up to 8 atmospheres.After inflation, the balloon did not completely deflate.Negative pressure was held for at least 15 seconds.A failed attempt was made to deflate the balloon using an indeflator and a 50cc syringe.The device was withdrawn partially inflated back to the introducer sheath.Upon removal the balloon wall separated from the catheter and remained in the vein.The balloon wall could not be retrieved using a lasso and migrated while attempting to snare it.It was suspected that the balloon piece finally migrated to a branch of the pulmonary artery.There was no hemodynamic consequence at the time because the piece is very small.There was no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual inspection was performed on the returned device.The separation was confirmed.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty to remove, shaft separation, removal of foreign body and additional treatment appears to be due to operation context of the procedure.It should be noted that the trek rx and mini trek rx, global 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 and balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction.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.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.(b)(4).

Event Description

Subsequent to the initial report, additional information indicates that resistance during withdrawal was noted due to the introducer sheath.No additional information was provided.

• 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
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5749528
• MDR Text Key: 48190773
• Report Number: 2024168-2016-04134
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 1012278-20
• Device Lot Number: 60126G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR