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

Catalog Number C-PMS-400-FA

Device Problem Tip breakage (1638)

Patient Problem Foreign body, removal of (2365)

Event Date 07/17/2014

Event Type  Injury  

Event Description

A portion of the device came off of the product inside of the pt.The procedure had to be stopped to perform a different procedure to remove the tip of the device from the pt's body.

Manufacturer Narrative

(b)(4).Eval: still under investigation.

• Brand Name: FEMORAL ARTERY PRESSURE MONITORING SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, dir ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4008224
• MDR Text Key: 4954518
• Report Number: 1820334-2014-00365
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Catalogue Number: C-PMS-400-FA
• Device Lot Number: 2862428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/17/2014
• Device Age: 3 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/23/2014
• Initial Date FDA Received: 08/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2011
• 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
• Patient Outcome(s): Other