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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2022

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Initial reporter name and address- (b)(6).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.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 the patient required replacement of the drainage catheter from a lock pericardiocentesis catheter set.The catheter was placed in the patient for thoracic cavity drainage.After one liter of pleural effusion was drained into a drainage bag, a nurse/physician clamped the tube of the drainage bag.An hour later, a nurse found the drainage catheter was severed.The catheter was replaced with a new drainage catheter.No other adverse effects were reported for this incident.

Manufacturer Narrative

Additional information: 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 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

Additional information was received confirming the catheter was not clamped.The ancillary drainage bag tubing was clamped with kelly forceps.Photos were provided showing catheter shaft separation near the hub.

Event Description

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

Manufacturer Narrative

E1: reporter name unknown, facility: (b)(6) hospital.Postal code: (b)(6).Phone: (b)(6).Investigation evaluation: (b)(6) hospital (japan) reported the catheter in a lock pericardiocentesis catheter set (rpn: c-pcs-830-lock; lot#: 13173802) separated.The device was placed in the patient¿s thoracic cavity at 19:00 on (b)(6) 2022 to treat pleural effusion.After 1 liter of fluid had drained into an ancillary drainage bag, the healthcare professional clamped the drainage tubing with clamping forceps.At 20:00, the nurse discovered that the catheter was separated.As a result, the catheter was removed and replaced.No other adverse effects were reported for this incident.A review of the documentation including complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control and specifications, as well as a visual inspection, and dimensional verification of the returned device were conducted during the investigation.The complaint device was returned a visual exam identified the shaft of the catheter to be separated approximately 5 mm from the catheter hub.The product¿s inner diameter was found to be within specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) showed that the risks associated with this device are acceptable when weighed against the benefits.A review of the dhrs for the reported complaint device lot (13173802) and the related subassembly lots revealed no recorded non-conformances relevant to the failure mode.It should be noted that there were no other complaints associated with the final product lot number.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: ¿intended use pericardiocentesis sets are intended to remove fluid from the pericardial sac.Instructions for use 11.Advance the catheter into the pericardium.13.If applicable, attach the appropriate connecting tube and prepare to aspirate¿ the evidence from the complaint file, quality control documents and complaint device indicate that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house.Cook confirmed this complaint based on customer testimony and product evaluation.It was noted that a clamp was placed on the drainage bag tubing after the fluid was collected which would add extra weight to the drainage bag.It is possible the weight from the drainage bag and the clamp contributed to this event, but this cannot be confirmed.Procedural or patient cause cannot be ruled out as a contributor to this event.The cause for this event is determined to be a component failure not due to manufacturing deficiencies.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.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.

• Brand Name: LOCK 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: 15874028
• MDR Text Key: 304421661
• Report Number: 1820334-2022-01776
• 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: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2023
• Device Model Number: N/A
• Device Catalogue Number: C-PCS-830-LOCK
• Device Lot Number: 13173802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 11/30/2022; 02/24/2023
• Supplement Dates FDA Received: 12/01/2022; 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2020
• 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 Sex: Male