MAUDE Adverse Event Report: COOK INC SINGLE LUMEN PRESSURE MONITORING SET; DQY CATHETER, PERCUTANEOUS

Catalog Number	C-PMS-500J
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
It was reported that the femoral line catheter of the single lumen pressure monitoring set was found to be cracked during a coronary artery bypass graft procedure.There were no injuries or additional procedures.

• Brand Name: SINGLE LUMEN PRESSURE MONITORING SET
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7588491
• Report Number: 1820334-2018-01775
• Device Sequence Number: 1396192
• Product Code: DQY
• UDI-Device Identifier: 00827002019164
• UDI-Public: (01)00827002019164(17)180203(10)5627631
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: C-PMS-500J
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1