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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate information s unknown or unavailable.Product code: itx.(b)(4).Event is currently under investigation.A follow-up/final report will be submitted upon receipt of additional information or completion of investigation.Blank fields on this form indicate information s unknown or unavailable.
Event or Problem Description
It was reported that the patient underwent a neck flap surgery and two doppler probes were placed to monitor blood flow, one on the artery and one on the vein.The signal from the probes was lost post-operatively and the patient was taken back to the operating room for an additional surgery to replace the probes.Upon retrieval of the initially placed probes, it was discovered there was a loose connection at the cuff.New probes were placed successfully and no additional consequences to the patient were reported.
Additional Manufacturer Narrative
Changed-device evaluated by mfg.: yes.Investigation summary: two devices for this complaint were returned for an investigation.A visual inspection and product evaluation was performed and complaint was confirmed that the cuff became detached from the crystal on sample 1, sample 2 still had the cuff attached to the crystal as designed.A dhr review was conducted, manufacturing and quality control records were reviewed and there is no evidence that defective product was shipped.There are no signs that this cuff was detached prior to shipment or that this device was not manufactured to current specifications.A quality engineering risk assessment concluded that no risk reduction is necessary.Investigation results concluded through visual inspection one cuff separated from crystal and the other probe remained intact.No other nonconformities or anomalies were observed on these devices.

• Brand Name: COOK-SWARTZ DOPPLER PROBE
• Common Device Name: DIAGNOSTIC ULTRASONIC TRANSDUCER
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7236929
• Report Number: 2522007-2018-00005
• Device Sequence Number: 1229363
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)200531(10)N146605
• 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: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2018

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?: Yes
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 04/24/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention