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

Catalog Number C-PMS-400-RA

Device Problem Split (2537)

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

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: pre-amendment.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported during insertion of arterial line post robotic urology surgery using a radial artery pressure monitoring set, the distal plastic end split when being fed over the wire guide.This did not cause damage to the wire guide and all plastic tip fragments were retrieved.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

A review of the drawings, documentation, manufacturing instructions, specifications, and quality control of the returned device was conducted during the investigation.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product was unable to be performed as the lot number for the device was not available.A complaint history search was also unable to be performed due to the lack of a lot number.Based on the information provided, no product returned, and the results of our investigation, a definitive cause could not be determined.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• Brand Name: RADIAL ARTERY PRESSURE MONITORING SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7484305
• MDR Text Key: 107363925
• Report Number: 1820334-2018-01154
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: C-PMS-400-RA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/03/2018
• Supplement Dates Manufacturer Received: 05/23/2018
• Supplement Dates FDA Received: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 DA