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

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 11/20/2017

Event Type  Injury  

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

The international customer reported that the cuff length of the cook-swartz doppler long cuff probe was not appropriate for use in the patient's head and neck.Additionally, the probe reportedly detached too early post implantation; it detached approximately 2 hours post implantation.The patient had to return to the operating room for a probe replacement, and the customer was concerned regarding potential added risk to which the patient would be exposed as a result.Additional information has been requested from the customer, but none is yet available.The device is reportedly unavailable for return and evaluation.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Investigation summary: reported event was confirmed via customer testimony as device was not returned for physical evaluation.Review of the device history record was unable to be performed as the lot number of the device involved in the event is unknown.Product literature was reviewed and this is a known failure mode of the device which will continue to be monitored according to established complaint monitoring procedures.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
• MDR Report Key: 7125966
• MDR Text Key: 95173878
• Report Number: 2522007-2017-00050
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K022649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 11/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention