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

Model Number N/A

Device Problem Unraveled Material (1664)

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

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510(k) #: exempt.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported an unknown patient required placement of a lock pericardiocentesis catheter set for an unknown procedure.During the procedure, the wire guide unraveled and the wire guide was removed.An x-ray showed no portion of the device was left inside the patient.Additional information regarding event details has been requested but is currently unavailable.

Event Description

Additional information provided on 16dec2021 indicated the needle was removed after inserting the wire guide.The wire guide unraveled when the wire guide was withdrawn with the pigtail catheter in place.Upon removal, it was noticed the wire guide was unraveled.There were no additional procedures.An x-ray of the abdomen confirmed there was no portion of the wire guide in the patient.

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: az-groeninge in belgium contacted cook stating that during a treatment of a patient, the wire guide from a lock pericardiocentesis catheter set unraveled.The wire guide unraveled when the catheter was in place and the wire guide was withdrawn.The wire guide was from a c-pcs-830-lock set from lot# 10066741.The wire guide was removed, and an x-ray confirmed that no part of the wire guide was left within the patient.There were no adverse effects for the patient and the patient did not require any additional procedures.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures of the device, as well as a visual inspection of photos provided by the customer, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.The customer did provide photographs to aid in the investigation.The photographs show the wire guide in an unraveled state.Additionally, a document based investigation evaluation was performed.The device master record (dmr) was reviewed and this product is 100% inspected for defects.The device history record for lot 10066741 was reviewed.The lot and relevant subassembly lots had no related nonconformances.A database search found no additional complaints on this lot.There is no evidence of nonconforming material in house or in the field.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: precautions: a tfe-coated wire guide must be used with the catheter in this set.Only the wire guide included in this set should be used with this catheter.Instructions for use: 5.Slide the safe-t-j wire guide straightener (positioned on the distal end of the wire guide) over the ¿j¿ portion of the wire guide and seat the straightener in the hub of the needle.6.Insert the wire guide through the needle and advance the wire guide into the pericardial sac.Note: the wire guide should advance without resistance.7.Leaving the wire guide in place, remove the needle.Create a small skin incision.If a dilator is included in set, the dilator should be advanced over the wire guide and removed prior to insertion of the catheter.9.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.11.Advance the catheter into the pericardium.Note: the wire guide should always extend beyond the catheter tip.12.Remove the wire guide.How supplied: upon removal from package inspect the product to ensure no damage has occurred.Based on the device master record, the device history record, and with no product return, it was determined the device was manufactured to specification.The customer provided photographs to aid in the investigation showing the wire guide in an unraveled state.The customer stated that the wire was not removed through the needle, as the needle had already been removed.The wire was noticed unraveled when it was removed for the catheter.This product is 100% inspected for defects.Based on the provided information, the cause of this event is component failure without design or manufacturing deficiency.The appropriate internal personnel have been notified.Per the risk assessment, no further action is required.Cook 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.

Event Description

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

• 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: 12975257
• MDR Text Key: 284144133
• Report Number: 1820334-2021-02657
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10827002024332
• UDI-Public: (01)10827002024332(17)221007(10)10066741
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2022
• Device Model Number: N/A
• Device Catalogue Number: C-PCS-830-LOCK
• Device Lot Number: 10066741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2019
• 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