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

Model Number	N/A
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code: itx.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 crystal detached from the cuff two days after the patients initial surgery, when the doppler was placed.The patient had to return to the operating room for a second surgery to replace the defective doppler flow probe.
Additional Manufacturer Narrative
Investigation summary: only a portion of the complaint device was returned for an investigation.The quality engineering department performed an investigation on the portion of the device returned.The wires and crystal were returned and inspected under magnification.The investigation revealed there was epoxy on one side of the crystal, and the opposite side of the crystal did not have epoxy remaining.The proximal section of the probe was cut from the probe and not returned.A functional test could not be performed on the probe since the cable was cut and not returned for investigation.A device history record was conducted which showed no evidence that a 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.

• 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: 7381334
• Report Number: 2522007-2018-00011
• Device Sequence Number: 18891823
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)200731(10)N148614
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: 03/01/2018
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 05/21/2018
• 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