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

Model Number	N/A
Medical Device Problem Codes	Detachment Of Device Component (1104); Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/23/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The international customer reported that the cook-swartz doppler probe cuff prematurely disconnected after it had already been implanted in the patient.The device had to be removed and replaced with another probe to correct the condition.The customer confirmed that no harm came to the patient, but it was reportedly inconvenient for the staff involved.It is unknown if the product will be returned; as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
(b)(4).Investigation summary: reported event was unable to be confirmed due to limited information received from the customer.The device history record was reviewed and no discrepancies were found.Device was not returned so no physical investigation could be conducted.Product literature was reviewed.This is a known failure mode of the device and will continue to be monitored according to established complaint monitoring procedures.A quality engineering risk assessment (qera) was completed and no risk reduction is necessary.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: 7133040
• Report Number: 2522007-2017-00049
• Device Sequence Number: 1068921
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)200831(10)N149379
• Combination Product (Y/N): N
• PMA/510(K) Number: K022649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: DP-SDP001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1