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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 03/31/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event - estimate.In the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.A review of the lot history record of the reported lot could not be conducted because the part and lot numbers were not provided.The reported patient effect of death is listed in the nc trek rx coronary dilatation catheters, instruction for use as a known patient effect.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The unk trek rx referenced is being filed under a separate medwatch report number.

Event Description

The following information was reported via a post market hospital data collection clinical study report identifying abbott coronary dilatation catheters (nc trek rx & trek rx) that may be related to the adverse patient effect of death.Details are listed, titled post market hospital data collection clinical study report.

• 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: 7673995
• MDR Text Key: 113547465
• Report Number: 2024168-2018-05192
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/10/2018

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2018
• Initial Date FDA Received: 07/10/2018
• 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): Death