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

Model Number	N/A
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The customer reported that the cook-swartz doppler probe doppler wires were coming loose post operatively, which necessitated the reopening of the patient's neck incision to determine what resulted in the loss of the doppler signal.The doppler malfunction reportedly directly contributed to the additional medical intervention.The patient's original procedure was a pharyngectomy with anterior lateral thigh free tissue transfer.
Additional Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed.Failure mode identified as defect code no.314, bond separation, which equates to the dfmea failure mode of "inadvertent cuff detachment, prior to, during or post procedure." dhr was reviewed and no discrepancies were found.Review of the complaint history identified trends and the event has been escalated within our internal processes (capa).The relevant capa was closed on december 6, 2017.A summary of the investigation has been sent to the complainant.

• Brand Name: COOK-SWARTZ DOPPLER PROBE
• Common Device Name: ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 6977047
• Report Number: 2522007-2017-00031
• Device Sequence Number: 13791131
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)200531(10)N147138
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K022649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: DP-SDP001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR