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

Model Number N/A

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

Patient Problems Hemorrhage/Bleeding (1888); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Common device name: itx.(b)(6).(b)(4).The event is currently under investigation.

Event Description

It was reported that an uneventful procedure was performed and a cook-swartz doppler probe was placed.(reportedly the facility protocol is to remove the probe 7 days post procedure.A micro-clip was used to secure the probe.The physician could not remember the direction in which the probe wire was placed).As required 7 days after the probe was implanted, the resident pulled out the implanted probe from the patient and immediately noticed hemorrhaging.The patient was taken to the operating room where it was discovered that when the probe was pulled out, it opened up the arterial anastomosis.The patient underwent urgent surgery to reattach the arterial anastomosis and stop the bleeding.The incision was not healing well following the reattachment of the arterial anastomosis and the patient had to undergo surgery to have a graft placed.It was reported the patient has had previous radiation treatment; therefore healing is more difficult.Patient is reported to currently be "fine.".

Manufacturer Narrative

A review of the complaint history and instructions for use (ifu) was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.The device is shipped with an instruction for use (ifu) that describes the intended use; specific items are addressed such as: precautions " avoid use of excessive force to remove the transducer assembly from the patient, which may cause injury to the blood vessel.If the transducer assembly cannot be removed using gentile traction, the transducer assembly should be removed surgically." potential adverse events listed in the ifu include: "inability to percutaneously remove the crystal after monitoring is complete" and "perforation or laceration of vessels, erosion, implant rejection, or device dislodgement/migration." based on the information provided, no product returned and the results of our investigation, user error and failure to follow instructions caused or contributed to the event.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5979396
• MDR Text Key: 55687655
• Report Number: 2522007-2016-00003
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K022649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2017

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?: 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
• Initial Date Manufacturer Received: 08/31/2016
• Initial Date FDA Received: 09/27/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/31/2017; 06/01/2017
• 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