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 or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code: itx.(b)(4).This 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
A doppler crystal prematurely separated from the cuff and the patient had to go through an additional procedure to replace the doppler.
Additional Manufacturer Narrative
Investigation summary: the complaint device was not returned and therefore a physical investigation could not be completed.The device history record was reviewed.There is no evidence that a defective product was manufactured.There are no signs that this cuff was detached prior to shipment or that this device was not manufactured to current specifications.Crystal epoxy separation is a known failure of this device.Capa 161942 was initiated to capture the correction activities of this failure.

• 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: 7472072
• Report Number: 2522007-2018-00014
• Device Sequence Number: 1543223
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)200731(10)N148611
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: DP-SDP001
• Device Lot Number: N148611
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 11/07/2018
• 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