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

Catalog Number	DP-SDP001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/01/2017
Type of Reportable Event	Serious Injury
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
As reported to customer relations: "the doppler was initially working when put in the patient, but crystal detached/slipped after the surgery was complete.The patient had to go back for a second surgery in order to replace the doppler.This required the patient to undergo a second general anesthesia, increased the risk of infection, increased the risk of neurovascular issues and delayed discharge from hospital.
Additional Manufacturer Narrative
Investigation/evaluation summary: the crystal/cuff was not returned with the doppler probe, only a section of the probe wire.The returned piece was inspected under magnification.A functional test could not be performed since a complete device was not returned.No other nonconformities or anomalies were observed on the device.A review of the device history record and manufacturing and quality control records was conducted.There is no evidence that defective product was manufactured using current drawings and device specifications.Complaints will continue to be monitored according to established complaint monitoring procedures.

• 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: 7048217
• Report Number: 2522007-2017-00042
• Device Sequence Number: 16423679
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)200731(10)N148387
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018

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 Catalogue Number: DP-SDP001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 02/07/2018
• 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