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

Catalog Number 1012452-12

Device Problem Detachment Of Device Component (1104)

Patient Problems Occlusion (1984); Foreign Body In Patient (2687)

Event Date 02/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device has not yet been 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 a heavily calcified distal circumflex artery. Pre-dilatation was performed with a 2. 5 x 12 mm trek and a 3. 0 x 18 mm xience alpine stent was deployed at 18 atmospheres. Post dilatation was performed with a 3. 0 x 12 nc trek to 20 atmospheres, then a 3. 5 x 12 mm nc trek at 20 atmospheres. A 3. 75 x 12 mm nc trek was also inflated to 20 atmospheres. When removed from the anatomy the tip was separated. There were several attempts with numerous guide wires to retrieve the tip, which took approximately two hours; however, the tip could not be removed and remains in the anatomy and the distal vessel is closed off. The procedure was completed at this time. There was a clinically significant delay in the procedure. No additional information was provided.

Manufacturer Narrative

(b)(4). The device was not returned. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. On march 14, 2017, abbott vascular decided to initiate a voluntary field action for some sizes and lots of the nc trek family of dilatation catheters for difficulty to remove sheath which may lead to inflation or deflation issues. [medwatch # 2024168-2017-02310].

Manufacturer Narrative

(b)(4). The device was not returned for evaluation. 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 similar incidents from this lot reported for tip separation. The reported patient effect of occlusion, as listed in the coronary dilatation catheter, nc trek rx, global, instructions for use is a known patient effect that may be associated with use of a coronary catheter in native coronary arteries. It should be noted coronary dilatation catheters (cdc), nc trek rx, global, instructions for use states: balloon pressure should not exceed the rated burst pressure (rbp). The rbp for the nc trek is 18 atms. The investigation determined the reported tip separation, occlusion, and foreign body in patient 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 this device.

• 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: 6433183
• MDR Text Key: 70857312
• Report Number: 2024168-2017-02509
• 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

• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 1012452-12
• Device Lot Number: 60909G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/24/2017 Patient Sequence Number: 1