MAUDE Adverse Event Report: COOK, INC. COOK, TPN DOUBLE LUMEN TPN CATHETER SET; FOZ, CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number C-TPNS-5.0D-65-12

Device Problem Dislodged (1179)

Patient Problem Bleeding (1738)

Event Date 04/23/2014

Event Type  Injury  

Event Description

The initial info provided to the mfr stated that during the procedure, the device became dislodged.However, on (b)(6) 2014, we received a fda medwatch report that provided more details.The pt came back from operating room at 12:00 after a cardiac catheterization procedure.The pt had some bleeding that required going back in the chest to control the bleeding.The pt recovered from this event and had some minor improvements.Approx an hour and a half later, the pt started to have massive bleeding from this chest tube and then had an asystole arrest.Cpr was started immediately and surgeons were at the bedside within minutes and in the chest to find the bleeding.The bleeding was found to be coming from the intracardiac broviac being dislodged.The bleeding was stopped and pt was placed on va-ecmo.From f/u review: pt had been explored early in the afternoon for bleeding.The pt had significant amount of chest tube output resulting in acute hypotension on retroflexion for initiation of chest compression.Decision was made for mediastinal exploration followed by a transthoracic ecmo cannulation, within the mediastinum; there did appear to be active bleeding from the atrial site of the dislodged intracardiac broviac and oa-line.After hemostasis was achieved, attention was turned to replacements of the qa line as well as the intracardiac broviac.In addition, adequate access was an issue and interosseous access was achieved and volume resuscitation was continued.Open cardiac message was continued throughout the procedure.During this time, the ecmo circuit was being prepared.Once the ecmo circuit was ready, the pt was transthoracically cannulated.Once the ecmo achieved full flow, attention was turned to further hemostasis.The broviac catheter was replaced and secured with another snare.Of note, the oa line had been dislodged during cannulation and the decision was made to leave the line out.Once hemostasis was achieved, delayed sternal closure was performed with the silastic membrane.The silastic membrane was sewn into place with 5-0 prolene suture.The silastic patch was cleaned and dried with sterile ioban dressing applied.The pt was stable on transthoracic ecmo.

Manufacturer Narrative

(b)(4).Event evaluation: the c-tpns-5.0d-65-12 catheter from product lot number f4595034 was returned in an open and used condition.A visual examination of the returned device noted a repair had been made to the catheter approx 8.2cm distal of the molded hub.Catheter shaft had an overall length of 23.9cm.Extension tubes and lumens were secure and intact.The synthetic fiber cuff measured 1cm, was intact, and showed no signs of splitting or detachment.The catheter was verified to be per spec.The investigation procedure included: dimensional verification, reviews of complaint history, device history record, drawing, ifu, qc, specs and a visual inspection.Per qc spec, there is confirmation that the correct cuff has been properly positioned on catheter, that the cuff is secure and clean and that the overall catheter surface is clean and free of damage or excessive imperfections.This device is shipped with an ifu that includes warnings and precautions.Design control activities have been conducted.A product-specific discrepancy that could have caused or contributed to this failure mode was not observed.Based on the limited info supplied the root cause of this event will remain inconclusive.We are unable to determine with certainty as to why this failure mode occurred.The appropriate personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment, the addition of this complaint does not change the conclusion that no further risk reduction is required.

• Brand Name: COOK, TPN DOUBLE LUMEN TPN CATHETER SET
• Type of Device: FOZ, CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, dir ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4210055
• MDR Text Key: 5154211
• Report Number: 1820334-2014-00550
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Catalogue Number: C-TPNS-5.0D-65-12
• Device Lot Number: F4595034
• Other Device ID Number: SEE FIELD H10
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/24/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2014
• Distributor Facility Aware Date: 04/23/2014
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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
• Patient Age: 6 DA
• Patient Weight: 4