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

Catalog Number 1012451-12

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for evaluation.The investigation determined the reported difficulties appear to be related to anatomical conditions.It should be noted that the nc trek rx instructions for use states: do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked; this may result in the shaft breaking.In this case, the resistance encountered caused the kink and separation.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 identified no other incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

It was reported that the procedure was performed to treat a heavily calcified proximal left anterior descending (lad) coronary artery.A 3.5x12mm nc trek rx balloon dilatation catheter (bdc) was advanced with resistance due to the heavy calcification in the entire lad.The physician stated that force was being placed on the bdc to attempt to cross the lesion, and therefore removed the bdc from the patient anatomy without reported issue.Upon removal, the distal shaft was noted to be bent; however, the physician reused the bdc for the procedure.The bdc was re-advanced in the patient anatomy and dilated the target lesion without issue.The balloon was then deflated, and the bdc was removed from the patient anatomy through the guiding catheter without issue; however, after the bdc was removed, the shaft snapped and separated where the bend was noted earlier in the procedure.Another trek bdc was used to further dilate the distal target lesion.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: NC 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: 8165030
• MDR Text Key: 130621806
• Report Number: 2024168-2018-09701
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151972
• UDI-Public: 08717648151972
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/14/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 1012451-12
• Device Lot Number: 80705G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2018
• 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 Age: 72 YR