MAUDE Adverse Event Report: COOK INC UNKNOWN; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

A patient informed cook on (b)(6) 2023 that a drainage catheter suture had been retained after the removal of a cook drainage catheter.The patient underwent an appendectomy and hernia repair on (b)(6) 2022.The patient was released from the facility.One to two weeks later the patient was hospitalized again for an infection.An unknown cook drainage catheter with a mac loc was placed in the patient's abdomen.The cook drainage catheter was in place for two weeks.When the catheter was removed, the catheter's suture was unable to be removed and was retained in the patient.The surgery department at the facility was contacted.The facility was unable to provide a device rpn or lot number and had no awareness of the event.The surgery department suggested that the patient submit a consent form if additional information was requested to be provided to cook.No adverse effects to the patient have been reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Customer (person): phone: (b)(6).Occupation: patient.Event occurred at indiana university (iu) health bloomington hospital, bloomington, indiana 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

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.On 30mar2023, cook was informed that the suture from an unknown cook drainage catheter was retained in the body of a 53-year-old, female patient.As reported, the patient had an appendectomy and hernia repair on (b)(6) 2022, at (b)(6) hospital.The patient was discharged to home but was re-hospitalized for infection approximately 1-2 weeks later.At this time, an unknown cook drainage device was placed in the abdomen.The drain was reportedly indwelling for two weeks.Upon attempted removal, difficulty was experienced.As a result, the physician cut the drain; however, a portion of the suture was unable to be removed and was retained in the patient.Communication with the facility where the device was placed provided no additional information regarding this event.Reviews of documentation including quality control procedures, specifications, and instructions for use (ifu) of the complaint 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.The rpn of the complaint device was not provided.During an expanded search, cook medical identified the ult8.5-38-25-p-6s-clm-rh, multipurpose drainage catheter as the most probable device, based on the amount of sales.A review of the device master record (dmr) of the suspected rpn concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A lot number was not provided.Cook medical performed a sales search from 30mar2020 up to 30mar2023 for the complaint device / lot.Due to the numerous amounts of lots sold to the reporting customer, cook medical was unable to identify the complaint lot.As a result, cook medical inc.Was unable to review the device history record.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.The ifu [t_multi2 rev1] packaged with the suspect device contains the following in relation to the reported failure mode: precautions: when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.A tfe-coated wire guide must be used with ultrathane catheters.Instructions for use: unlocking catheter loop.For mac-loc locking loop mechanism: a.While stabilizing the mac-loc catheter hub assembly with one hand, position a small, blunt object (approximately the shape and size of a ball point pen or small forceps) into the mac-loc release notch.B.Pry upward until the locking cam lever is free.(fig.4) how supplied: upon removal from package, inspect the product to ensure no damage has occurred.Based on the available information, no product returned, and the results of the investigation, cook concluded the cause of this event is traced to 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 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: UNKNOWN
• 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: 16725548
• MDR Text Key: 313191142
• Report Number: 1820334-2023-00418
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 08/22/2023
• Supplement Dates FDA Received: 09/11/2023
• 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): Other
• Patient Age: 53 YR
• Patient Sex: Female