MAUDE Adverse Event Report: COOK INC FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET; GBX CATHETER, IRRIGATION

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem Hematoma (1884)

Event Date 01/30/2023

Event Type  Injury  

Manufacturer Narrative

Customer (person): phone: (b)(6).Customer fax: (b)(6).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

It was reported that during the placement of the drain from the fuhrman pleural/pneumopericardial drainage set, a patient experienced a venous wound.During the placement of the drain for drainage, the wire guide of the drainage set created a venous wound at the level of the upper left pulmonary vein of a 25-year-old, male patient.After the placement of the drain, the venous wound was not noticed immediately.The patient rapidly deteriorated due to the formation of a significant hematoma in the thoracic level.He was emergently transferred to amiens university hospital where the wound was sutured by a vascular surgeon.The installer is a confirmed resuscitator.The wire guide was thrown away in the ward after placement due to not noticing at the beginning of the procedure the pulmonary vein was touched.No other adverse effects were reported for this incident.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

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 08mar2023, it was confirmed that the curved end of the wire guide was inserted first.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation it was reported by (b)(6) hospital that on (b)(6) 2023 the wire guide in a fuhrman pleural/pneumopericardial drainage set (rpn: c-ppd-850-imh; lot#: unknown) punctured the pulmonary vein.The device was required by a 25-year-old male for treatment of a pneumothorax.During placement of the device, the wire guide punctured the left superior pulmonary vein; however, the drain was placed.A significant hematoma quickly developed at the thoracic level.As a result, the patient was emergently transferred to (b)(6) hospital for suture of the wound by a vascular surgeon.No other adverse events were reported due to this occurrence.Reviews of the complaint history, device history record (dhr), manufacturing instructions, and quality control procedures for the device 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.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that process steps were identified to ensure non-conforming material does not leave house.A review of the device history record (dhr) was unable to be completed due to a lack of lot information.A sales report was performed and reviewed for this complaint.There were too many possible lots to determine a lot for this complaint.Based on the available information, cook was not able to find evidence the product was manufactured out of specification.Cook was not able to find evidence of non-conforming material in house or in the field.Cook also reviewed product labeling.This product is supplied with an instructions for use (ifu) pamphlet, c_t_ppd_rev6.In the warnings section it states: over-insertion of the access needle, wire guide, dilator, or chest tube may result in serious or life-threatening injury¿ the wire guide should always advance without impedance to avoid perforation of any surrounding structures.The wire guide should always extend beyond the catheter tip to avoid perforation of any surrounding structures.In the instructions for use section, it states: 6.) introduce the wire guide and gently advance it into the selected cavity.Note: the wire guide should advance without impedance.In the how supplied section it states: upon removal from package, inspect the ensure no damage has occurred.Based on the information provided, no returned device, and the results of the investigation, a cause of failure could not be established.It was reported that the wire guide punctured the left superior pulmonary vein which led to bleeding and pooling of blood.It is possible that the device was over-inserted into the patient.There is no information regarding patient anatomy, so it's possible the vein was closer to the surface of the lung than expected.This event could have also been due to a wire guide that was too stiff; however, the product was not returned, so the product cannot be confirmed to have been manufactured out of specification.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 or that a death or serious injury occurred; nor is it admission 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: FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE 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: 16364803
• MDR Text Key: 309419226
• Report Number: 1820334-2023-00125
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PPD-850-IMH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2023
• 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): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male