MAUDE Adverse Event Report: COOK INC FEMORAL ARTERY PRESSURE MONITORING SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Unraveled Material (1664)

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

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

Customer reported that a patient was undergoing placement of a femoral artery pressure monitoring catheter.The customer reported that the wire guide kinked and frayed during placement.The actions taken by the clinical staff to address this issue are no known.Additional information was requested.There are no reported adverse patient consequences.The device is reportedly available for evaluation; however it has not been received by the manufacturer as of the date of this report.

Manufacturer Narrative

Corrected data: device was returned to manufacturer and was examined.Investigation - evaluation: a review of drawing, manufacturing instructions, specifications and quality control data was conducted during the investigation.A device history record review could not be performed as the complaint lot number was not provided.A visual examination of the returned sf-21-40 wire guide confirmed damage to the wire near the distal end.The distal weld connection separated at the mandrel wire and coil, resulting in coil elongation.There were no adverse effects to the patient due to this occurrence.A number of training certifications, manufacturing instructions, and quality instructions ensure that the parts are manufactured to specification.There is no evidence to indicate that the device was not manufactured to specification and this device is inspected 100% for bends, kinks, adequate joint strength, correct outside dimension and other surface imperfections prior to transport.We will continue to monitor for similar complaints.Based on the provided information a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: FEMORAL ARTERY PRESSURE MONITORING SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6683457
• MDR Text Key: 78959094
• Report Number: 1820334-2017-01606
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2017
• 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: C-PMS-400-FA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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