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

Catalog Number 1012451-08

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problems Bradycardia (1751); Non specific EKG/ECG Changes (1817); Occlusion (1984)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.The reported patient effect of occlusion, as listed in the nc trek rx instructions for use is a known patient effect that may be associated with use of a coronary catheter in native coronary arteries.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 identified no other incidents from this lot.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 and subsequent patient effects appears to be related to circumstances of the procedure.

Event Description

It was reported that the procedure was to treat a lesion located in the proximal right coronary artery (rca).Resistance was not felt during advancement of the 3.5 x 8 mm nc trek rx balloon dilatation catheter (bdc) and it crossed successfully; however, the bdc was unable to be fully deflated.Deflation was attempted several times using aspiration and different syringe sizes without success.The vessel remained occluded for approximately 3 minutes before the balloon was finally deflated when the bdc was pulled with force through the guiding catheter.The procedure was completed after a bioresorbable vascular scaffold was implanted with good patient outcome.A clinically significant delay in the procedure was reported due to st elevation and bradycardia as a result of the prolonged vessel occlusion caused by the undeflated balloon.No additional information was provided.

Manufacturer Narrative

(b)(4).The device returned for analysis.The complaint investigation determined the reported difficulty was related to manufacturing issues associated with the protective sheath.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 [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
• 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: 6194115
• MDR Text Key: 62963634
• Report Number: 2024168-2016-09101
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151965
• UDI-Public: (01)08717648151965(17)190630(10)60713G1
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/05/2017

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: 06/30/2019
• Device Catalogue Number: 1012451-08
• Device Lot Number: 60713G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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
• Treatment: GUIDE WIRE: RUNTHROUGH
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR