MAUDE Adverse Event Report: COOK INC ULTRATHANE PIGTAIL MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 04/10/2022

Event Type  Injury  

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 a patient required an ultrathane pigtail multipurpose drainage catheter for a nephrostomy.Three days after placement, the operator noted the hub separated from the catheter and the drainage bag could not be connected.The catheter was then replaced with a new similar device.No other adverse effects were reported for this incident.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5.Correction: h6-annex a.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 information was received on 14may2022.The drainage catheter was connected to a drainage bag to collect urine.It was confirmed that the shaft of the catheter was separated.The hub of the catheter was not separated from the catheter.

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

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

Event Description

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

Manufacturer Narrative

Investigation ¿ evaluation on 20apr2022, it was reported by a representative from (b)(6) in france, that an ultrathane pigtail multipurpose drainage catheter (rpn: ult8.5-38-25-p-6s-mdc; lo#: 14424933) separated in a patient.The device was required for a nephrostomy tube and was placed in the patient on (b)(6) 2022.About three days later, on (b)(6) 2022, it was discovered the catheter tubing, at approximately mid-point.Had separated in the patient.As a result, the patient required an additional procedure to replace the device.No other adverse events were reported due to this occurrence.A review of the complaint history, device history record, instructions for use (ifu), quality control procedures, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.Additionally, a document-based investigation evaluation was performed.Cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for lot 14424933 and its associated subassembly lots confirmed there were no relevant recorded non-conformances.A review of complaint history found no additional complaints associated with the lot.As there are adequate inspection activities established, with objective evidence the dhr was fully executed, and there are no other lot-related complaints that have been received from the field, it was concluded that the device was manufactured to specification and there is no evidence that non-conforming product exists in house or in the field.Cook also reviewed product labeling.The product¿s instructions for use [ifu], ¿multipurpose drainage catheter¿ [t_multi_rev5], provides the following information to the user related to the reported failure mode: warnings: if a catheter has become malpositioned or if drainage ceases, the catheter should be promptly exchanged or removed.Instructions for use: once catheter is in desired location, remove any wire guides, trocars, or stiffeners, allowing the catheter to form its configuration.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.A definitive conclusion could not be determined regarding how the catheter tubing was severed.Findings of this investigation revealed no evidence to suggest the device was manufactured out of specification.Based on the device evaluation, cook medical has determined the root cause category would fall under cause traced to component failure, being defined as component failure without any design or manufacturing issue.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.

• Brand Name: ULTRATHANE PIGTAIL MULTIPURPOSE DRAINAGE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• 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: 14270281
• MDR Text Key: 292386429
• Report Number: 1820334-2022-00675
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002064836
• UDI-Public: (01)00827002064836(17)241216(10)14424933
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/28/2022

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 Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-6S-MDC
• Device Lot Number: 14424933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/03/2022
• Supplement Dates Manufacturer Received: 05/03/2022; 05/14/2022; 07/26/2022
• Supplement Dates FDA Received: 05/05/2022; 05/26/2022; 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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
• Treatment: CTU14.0-30-ST; DRAINAGE BAG FROM UNKNOWN MANUFACTURER
• Patient Outcome(s): Required Intervention
• Patient Sex: Female