MAUDE Adverse Event Report: COOK INC SINGLE LUMEN DISTAL AORTIC PRESSURE MONITORING SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Break (1069)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 04/28/2017

Event Type  Injury  

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 had a single lumen distal aortic pressure monitoring catheter implanted on an unknown date.The customer reports that the arterial line site appeared to be bleeding.Upon closer inspection, the arterial line catheter was cracked on both sides of the hub just distal to the patient insertion site (mdr# 1820334-2017-01286.) the subject line was explanted and replaced.The customer reported a second occurrence (mdr # 1820334-2017-01471) with the same patient within 24 hours of the replacement.The handling conditions and circumstances surrounding the event are not known.A device is reportedly available for evaluation, however the device has not been received by the manufacturer.Additional information was requested; no further information was received.

Manufacturer Narrative

Add'l info: event description: the left femoral arterial line cracked/tore while in situ with no manipulation by the nurse.The crack/tear led to significant bleeding from the site.A blood transfusion was given as a result.Unspecified additional treatment and monitoring were administered to the patient as a result.Several attempts have been made to request the alleged device.No product was received.(b)(4).: initially reported to fda : previously answered ¿yes.¿ since the event occurred in (b)(6), it is presumed that the report was submitted to (b)(6), not fda.Investigation - evaluation a review of the documentation and specifications was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.The lot number of the device is not known; accordingly a review of the device history record and complaint history of the lot could not be conducted.Based on the investigation, there is no indication that a design or process-related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: SINGLE LUMEN DISTAL AORTIC 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: 6614087
• MDR Text Key: 76733138
• Report Number: 1820334-2017-01471
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-501J-DAP-PKG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2017
• Initial Date FDA Received: 06/06/2017
• Supplement Dates Manufacturer Received: 09/27/2017
• Supplement Dates FDA Received: 10/23/2017
• 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
• Patient Outcome(s): Required Intervention