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

Model Number N/A

Device Problems Detachment Of Device Component (1104); Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/23/2017

Event Type  malfunction  

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 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.

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
• Type of Device: ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7133040
• MDR Text Key: 95829951
• Report Number: 2522007-2017-00049
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)200831(10)N149379
• Combination Product (y/n): N
• PMA/PMN Number: K022649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: DP-SDP001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/27/2017
• Date Device Manufactured: 09/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1