MAUDE Adverse Event Report: COOK INC TEITEL PEDIATRIC PERICARDIOCENTESIS CATHETER SET; GBX CATHETER, IRRIGATION

Catalog Number C-PCS-500-TTL

Device Problem Malposition of Device (2616)

Patient Problem Cardiac Arrest (1762)

Event Date 01/03/2019

Event Type  Death  

Manufacturer Narrative

Pma/510(k) #: exempt.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 that a teitel pediatric pericardiocentesis catheter set was placed in a study patient's left xiphocostal area.The device was placed in the incorrect anatomical location.Based on real-time echocardiography, there was a pericardial effusion.Therefore, the drain was replaced immediately.Due to the misplacement of the device along with "multiple other factors", the patient went into cardiac arrest.Ultimately, the patient died.Additional information regarding the patient death and the event has been requested but is currently unavailable.

Event Description

In additional information received on 18nov2021, it was reported that multiple things contributed to the patient's death, including: refractory ventricular tachycardia, low cardiac output and tamponade physiology.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional clarification regarding the date of the event was received on 02dec2021.It was reported that the initial drain placement and replacement occurred on (b)(6) 2019.The replacement drain was removed on (b)(6) 2019 due to the patient's death.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

In additional information received on 17nov2021, it was reported that the date of the event was the same day as the procedure.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Investigation ¿ evaluation: on 09nov2022, cook was informed via post market clinical follow-up (pmcf) study (b)(6) of an adverse event involving a teitel pediatric pericardiocentesis catheter set (rpn: c-pcs-500-ttl; lot unknown) placed in a suboptimal position at the children's hospital med.Ctr.The device was required by a 4-month-old female patient for a pericardial drain placement in the left xiphocostal area.During the procedure on (b)(6) 2019, the device was placed in the incorrect anatomical location.¿the misplacement along with multiple other factors induced cardiac arrest.¿ based on real-time echocardiography, there was a pericardial effusion.Therefore, the drain was replaced immediately.The following day, on (b)(6) 2019, the patient expired.The replacement drain was then removed following patient death.It was reported that multiple things contributed to the patient¿s death including refractory ventricular tachycardia, low cardiac output, and tamponade physiology.A review of instructions for use (ifu) and quality control procedures were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) was unable to be completed due to a lack of lot information.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.This product is supplied with an instructions for use (ifu) pamphlet c_t_ttps_rev10.In the precautions section it states: standard pericardiocentesis techniques should be employed.In the instructions for use section, it states: introduce the catheter (with stiffening cannula, if applicable) over the wire guide and advance until the tip of the catheter is posterior to the muscle fascia.If the set contains a catheter with stiffening cannula, remove the cannula with a twisting motion, while holding the catheter and wire guide in place.Advance the catheter into the pericardium.In the how supplied section it states: upon removal from package inspect the product to ensure no damage has occurred.Based on the information provided, no returned product, and the results of the investigation, cook concluded there is no indication the device failed.No problem was detected.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: TEITEL PEDIATRIC PERICARDIOCENTESIS CATHETER SET
• Type of Device: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12815254
• MDR Text Key: 280781662
• Report Number: 1820334-2021-02499
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-PCS-500-TTL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2022
• 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
• Patient Outcome(s): Death
• Patient Age: 4 MO
• Patient Sex: Female
• Patient Weight: 5 KG