MAUDE Adverse Event Report: CARDIAC CATHETERIZATION 4-STATION HIGH PRESSURE STOPCOCK MANIFOLD (OFF HANDLES); CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 423100401

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 08/26/2021

Event Type  Injury  

Manufacturer Narrative

The device is available to evaluation however it has not yet been received.The lot number of the device that was in use is unknown.The customer identified one possible lot number (plots).The possible lot number is 5190028 (expiry date 02/01/2024, mfr date 02/01/2021).

Event Description

The event involved a cardiac catheterization 4-station high pressure stopcock manifold (off handles).The customer reported that the device cracked and found it to be leaking.The crack was located on the hub where the intravenous (iv) tubing is connected to the manifold.The following medications were reported to be infusing norepinephrine, vasopressin, epinephrine, and propofol, however they are unsure which port was used for each drug.The patient's blood pressure dropped dangerously low and necessitated some chest compressions by the cardiothoracic surgeon in the room.The patient's blood pressure was stabilized when the iv was rerouted.The iv tubing was the only thing connected to that port.There was patient involvement and a report of adverse event.

Manufacturer Narrative

The reported complaint of leakage was confirmed.No product samples, videos were returned for investigation.However an image was provided by the customer showing a crack on the female luer.Crazing was observed around the crack in the image provided by the customer.The probable cause of the crack on the female luer had occurred due to environmental stress cracking during use.The device history review (dhr) for lot 5190028 was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: CARDIAC CATHETERIZATION 4-STATION HIGH PRESSURE STOPCOCK MANIFOLD (OFF HANDLES)
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 12521833
• MDR Text Key: 272998177
• Report Number: 9617594-2021-00264
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00887709043312
• UDI-Public: (01)00887709043312(17)240201(10)5190028
• Combination Product (y/n): N
• PMA/PMN Number: K932141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 423100401
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: EPINEPHRINE, MFR UNK; NOREPINEPHRINE, MFR UNK; PROPOFOL, MFR UNK; UNSPECIFIED TUBING SET, MFR UNK; VASOPRESSIN, MFR UNK; EPINEPHRINE, MFR UNK; NOREPINEPHRINE, MFR UNK; PROPOFOL, MFR UNK; UNSPECIFIED TUBING SET, MFR UNK; VASOPRESSIN, MFR UNK
• Patient Outcome(s): Life Threatening; Required Intervention