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

Catalog Number	1012452-08
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.It was reported that the contrast mix ratio used was 60% saline and 40% contrast.It should be noted that the nc trek rx, instructions for use (ifu) specifies that the contrast should be 60% contrast medium diluted 1:1 with normal saline.Additionally the ifu 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 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 of the reported lot did not indicate a lot specific quality issue.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.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the difficulty to remove appears to be related to circumstances of the procedure.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion located in the mildly tortuous, mildly calcified, mid left anterior descending artery.After one inflation of the 3.75 x 8 mm nc trek balloon to 18 atmospheres successfully for predilatation of the lesion, the balloon could not be deflated at all and was removed using force, while still inflated.The contrast ratio used was 60% saline and 40% contrast.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).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.Abbott vascular performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.The root cause identification was complicated by the fact that users were describing multiple symptoms when reporting the complaints.To date, the frequency of worldwide reported events for difficulties removing the protective balloon sheath, inflation and deflation has reached an actionable limit, thus abbott vascular communicated the voluntary field action to the fda on march 17, 2017 [medwatch # 2024168-2017-02310].Corrective action has been implemented per site operating procedures.The product will continue to be trended.The abbott internal recall number is 2024168-3/14/2017-002-r.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6094119
• Report Number: 2024168-2016-07851
• Device Sequence Number: 363788
• Product Code: LOX
• UDI-Device Identifier: 08717648152016
• UDI-Public: (01)08717648152016(17)190531(10)60603G1
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 1012452-08
• Device Lot Number: 60603G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2016
• Supplement Report FDA Received Date: 03/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 72