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

Model Number N/A

Device Problem Failure to Disconnect (2541)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Investigation/evaluation: reported event was confirmed via customer testimony, review of complaint history, and literature review. Actual device was not returned so physical evaluation could not be formed. Precautions identified in the instructions for use state: "to avoid use of excessive force when removing transducer assembly from the patient as it may cause injury to the blood vessel. If the transducer assembly cannot be removed using gentle traction, the transducer assembly should be removed surgically". Also included in the instructions for use are potential adverse events such as perforation or laceration of vessels and device dislodgement/migration. A review of the device history record could not be performed as no lot number was provided for the involved device. Investigation results concluded that the reported event was due to product use or handling related in operational and/or environmental context. A summary of the investigation has been sent to the complainant.

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

Customer reported that a patient underwent a free-flap surgical procedure. A cook-swartz doppler probe was used to monitor blood flow to the anastomotic site. The anastomotic site was damaged during planned removal of the device five (5) days following implant. A description of the damage and extent was not provided. The patient was returned to surgery for site exploration and a reanastomosis of the vessel. No further event or patient information was provided. The instructions for use (ifu) that accompany the device cautions the user to "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 gentle traction, the transducer should be removed surgically. " the ifu also lists potential adverse events which include ". Separation of the doppler crystal from the cuff, inability to percutaneously remove the crystal when monitoring is complete,. ".

• 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
• MDR Report Key: 6649588
• MDR Text Key: 197201781
• Report Number: 2522007-2017-00024
• Device Sequence Number: 1
• Product Code: ITX
• 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: health professional,user faci

Reporter Occupation

• 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: 06/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: DP-SDP001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/20/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/19/2017 Patient Sequence Number: 1