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

Catalog Number 1012276-15

Device Problems Detachment Of Device Component (1104); Inflation Problem (1310); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The procedure was successfully completed via placement of another unspecified stent in the lm to lad.There was no occurrence of a clinically significant delay.No additional information was provided.(b)(4).Product performance engineering reviewed the incident information and analysis of the returned product.The balloon catheter was returned with blood in the guide wire lumen and on the entire length of the device.There was crystallized contrast in the outer member.The balloon was loosely folded.The balloon, including the tip was folded in towards itself, for a length of 1cm, thus the reported tip separation was not confirmed.The tip folding in over itself likely gave the impression of a separation; therefore a follow up with the account will not be required.The distal balloon marker was located within the proximal balloon seal and the proximal balloon marker was located on the inner member 1.5cm proximal to the proximal balloon seal likely due to the separation.The outer member was separated distal to the mid lap seal, thus confirming the reported separation.Therefore, no attempt will be made to inflate the balloon catheter.The material at the separation was stretched and jagged.The inner member was separated 7mm distal to the guide wire exit notch.The material at the separation was stretched and jagged.Based on the balloon as returned condition and the separations noted, no attempt will be made to advance the balloon catheter through a proxy guiding catheter.There was no other damage noted to the balloon catheter.The guiding catheter used during the procedure was not returned.Therefore, the inner diameter could not be measured.The product risk assessment identifies this as a foreseeable event; as such, design and manufacturing controls and mitigations have been established for potential causes.There was no damage noted to the balloon catheter during the inspection prior to use or during inflation, which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is likely that the balloon interacted with the lesion site during inflation causing the balloon to slip.The bend in the guiding catheter likely contributed to the resistance met during removal such that when force was applied the shaft and tip separated.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global instructions for use (ifu, ppl2094606 revision d, warning section) states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and/or damage/separation of the catheter.A notification letter will be requested for the account to address the deviation(s) from the instructions for use and its associated potential adverse events.Visual inspections were performed on the returned device.The reported shaft separation was confirmed.The reported tip separation was not confirmed.The reported slipping of the balloon during inflation could not be replicated in a testing environment as it was based on operational circumstances.The reported resistance with the guiding catheter could not be tested due to the condition of the returned device.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties and foreign body in patient appear to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the patient presented with in-stent restenosis of a prior unspecified stent that had been implanted at an unknown date in the ostial circumflex coronary (cx) artery with the stent extending into the left main (lm) coronary artery.The patient also presented with a de novo lesion in the lm to ostial left anterior descending (lad) coronary artery.With an unspecified guide wire positioned in the cx and another unspecified guide wire positioned in the lad, a 3.5x15mm trek rx balloon dilatation catheter (bdc) was unpackaged and prepped without issue and was advanced without resistance to the lm to lad area to perform mini crush of the stent extending from the cx to lm area (to enable placement of a stent in the lm to lad).When inflating the trek rx balloon, it would watermelon-seeded proximally, but was ultimately able to be re-positioned and complete the stent mini crush technique.There were no other inflation issues and the balloon was completely deflated without issue.When withdrawing the deflated trek rx bdc, however, it became stuck at a bend in the guiding catheter, very slight force was applied, and the middle of the shaft separated.The trek rx and guiding catheter were withdrawn as a single unit without further resistance, but the distal tip of the trek rx bdc was noted to have separated and was missing.The tip was unable to be located in the patient or outside of the patient.The physician searched for the tip but was unable to confirm if the tip resides in patient anatomy.As there were no adverse patient sequelae, no intervention was performed to further search for and remove the tip if found.

• 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: 6358761
• MDR Text Key: 68350465
• Report Number: 2024168-2017-01538
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138577
• UDI-Public: (01)08717648138577(17)180531(10)50626G1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 1012276-15
• Device Lot Number: 50626G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2017
• Initial Date FDA Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2015
• 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): Other
• Patient Age: 69 YR