MAUDE Adverse Event Report: COOK VASCULAR INC COOK-SWARTZ DOPPLER PROBE; ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported that the patient underwent an esophagectomy procedure with jejunal graft.The physician attached a cook-swartz doppler probe but it malfunctioned.The physician used another cook-swartz doppler probe, which functioned for a certain amount of time, but later failed.The patient underwent two additional procedures in relation to this issue since the physician was not able to detect the blood flow via the probe.Additional information was requested regarding the failure of the device and the two additional procedures.No additional information has been provided at this time.

Manufacturer Narrative

Investigation/evaluation: complaint was evaluated and reported event was confirmed via customer testimony, review of complaint history, review of device history record, and review of documentation.The instructions for use list a loss of reception or transmission of ultrasound monitoring signal as a potential adverse event.The device history record was reviewed, including the manufacturing and quality control records, and there were no signs to indicate that nonconforming devices were sent to the field.The root cause is unable to be determined because the device was not returned; therefore, a physical investigation could not be performed.A summary of the investigation has been sent to the complainant.

• Brand Name: COOK-SWARTZ DOPPLER PROBE
• Type of Device: ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: brian johnston ; 1186 montgomery lane; vandergrift, PA 15690 ; 4128458621
• MDR Report Key: 6499539
• MDR Text Key: 72990987
• Report Number: 2522007-2017-00015
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)190930(10)N141043.1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: DP-SDP001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2017
• Date Device Manufactured: 10/12/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR