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

Catalog Number 1012451-20

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intimal Dissection (1333)

Event Date 01/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) during processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: fielder, balance middleweight, sion blue, guide catheter : al1 6f, 7f; ebu 3.5 7f, other: finecross 150 microcatheter; guideliner.(b)(4) the customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that pre-dilatation was performed in the mid right coronary artery (rca) with a 2.5 x 20 mm nc trek balloon at 12 atmospheres (atm).Additional pre-dilatation was done in the mid rca to proximal rca with a 3.5 x 20 mm nc trek balloon at 12 to 22 atm, 7 times.Follow-up angiography revealed significant residual stenosis and type 'a' dissection from mid to proximal rca.A 3.5 x 28 mm implant was deployed in the mid rca and a 3.5 x 18 mm implant was deployed in the proximal rca post-dilatation was done with a 3.75 x 15 mm nc trek balloon.The final angiographic residual stenosis was less than 10%.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A cine of the procedure was returned and reviewed by an abbott vascular clinical specialist who confirmed the dissection.The reported patient effect of intimal dissection is listed in the nc trek rx instructions for use (ifu) as a known patient effect.Additionally, the ifu warns: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek rx device is 18 atms; therefore rbp was exceeded.There is no indication of a product quality issue with respect to manufacture, design or labeling.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.

• 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): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 5498374
• MDR Text Key: 40247452
• Report Number: 2024168-2016-01577
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1012451-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 54 YR