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

Catalog Number 1012451-20

Device Problems Detachment Of Device Component (1104); Kinked (1339); 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 06/05/2018

Event Type  Injury  

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 received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported the procedure was to treat a heavily tortuous and calcified lesion in the circumflex (cx) artery.The 3.50x20mm nc trek balloon catheter was noted to be kinked prior to use however was advanced in the guiding catheter.Resistance was met during advancement and retraction in the guiding catheter and the hypotube separated.The proximal portion was removed from the guiding catheter however the distal portion was still inside therefore a 2.5mm rx trek balloon catheter was advanced to assist in retrieving the 3.50 nc trek.All the devices were removed as a system.Another 3.5mm nc trek was used to complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual and dimensional inspections were performed on the returned device.The reported kink and separation were confirmed.The reported difficulty to position and difficulty removing the device could not be replicated in a testing environment 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 identified no other incidents from this lot.The investigation determined the reported difficulty positioning and retracting the device and separation appear to be related to user error; however, the reported kink and additional treatment appear to be related to operational context.It should be noted the nc trek instructions for use (ifu) states: prior to use examine all equipment carefully for defects.Examine the dilatation catheter for bends, kinks, or other damage.Do not use any defective equipment.Additionally, the warning section of the ifu 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.It is possible that the ifu violations caused and contributed to the reported difficulties.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initially filed medwatch report additional information was received stating the physician kinked the shaft and attempted to straighten it out.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: 7626140
• MDR Text Key: 111915685
• Report Number: 2024168-2018-04780
• Device Sequence Number: 1
• Product Code: LOX
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 1012451-20
• Device Lot Number: 80409G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 73