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

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problems Pain (1994); Pneumothorax (2012); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/23/2022

Event Type  Injury  

Manufacturer Narrative

Suspect medical device: product information currently unavailable.Device reported to be a mac-loc drain occupation: unknown.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 a cook mac-loc pigtail product (rpn and lot number were not given by customer) was unable to be unlocked while attempting to be removed from the patient.While attempting to remove the catheter by unlocking the mac-loc, the string would not disengage at the tip of the pigtail drain, causing the pigtail to remain locked.Cook personnel was notified of the situation the day of removal and advised the customer to send the patient to radiology for assistance.However, the catheter had already been cut, clamped, and removed by the doctor after the suture and dressing were removed.The pigtail was observed to still be locked once removed from the patient.The removal process was very painful for the patient.Two days after the removal of the mac-loc pigtail product, the patient developed pneumothorax; however, the exact cause is unknown.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

Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5, h6 - annex e.H6 - annex e: e2402 - appropriate term / code not available - subcutaneous emphysema.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 08sep2022, it was reported that difficulty was experienced when removing the 12fr mac-loc despite unlocking.The respiratory advanced trainee clamped and cut the tube to pull it out; however the catheter was not fully straightened.This caused the patient discomfort and pain.A post removal chest x-ray revealed a pneumothorax and the patient developed substantial subcutaneous emphysema.

Event Description

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

Manufacturer Narrative

Investigation ¿ evaluation it was reported by mayrose chan of concord hospital nsw (australia), that the pigtail of a 12fr mac-loc catheter (rpn: unknown; lot#: unknown) would not unlock.The device was placed in the patient for treatment of a pleural effusion.Later, on (b)(6)2022, when the device was being removed, the mac-loc was unlocked, but the pigtail remained curled.A cook representative was contacted for advice, and they suggested the patient be sent to radiology for assistance.The customer indicated this was not feasible as the dressing and sutures had been removed.A respiratory advanced trainee elected to clamp and cut the catheter.The device was then removed from the patient.The patient experienced discomfort and pain during removal and it was noted the pigtail did not fully straighten.A chest x-ray (cxr) taken after device removal showed the patient had developed a pneumothorax and substantial subcutaneous emphysema was observed.No other adverse effects were reported.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu), manufacturing instructions and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examinations could be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient controls are in place to detect this failure mode prior to release.A review of the device history record (dhr) could not be conducted, due to the lack of lot information provided by the facility.Cook medical performed an expanded sales search for the reported ult12.0 fr mac-loc catheter shipped to this customer between (b)(6)2019 until (b)(6)2022; however, the lot was unable to be identified.Cook also reviewed product labeling.The instructions for use (ifu) [ t_multi_rev5, multipurpose drainage catheter] states the following.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.Intended use: multiple drainage catheters are intended for percutaneous drainage applications (e.G nephrostomy, biliary and abscess), either by direct stick or seldinger access technique.Warnings: if a catheter has become malposition or if drainage ceases, the catheter should be promptly exchanged or removed.References: these instructions for use are based on experience from physicians and (or) their published literature.Refer to your local cook sales representative for information on available literature.Evidence gathered from reviews of the dmr and ifu, suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, no returned product and the results of our investigation, it was concluded that a component failure without any design or manufacturing issue likely led to the reported event.The appropriate personnel have been notified.Per the 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.

• 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: 15490846
• MDR Text Key: 300664119
• Report Number: 1820334-2022-01460
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2022

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/27/2022
• Supplement Dates Manufacturer Received: 09/08/2022; 11/14/2022
• Supplement Dates FDA Received: 10/03/2022; 11/15/2022
• 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): Life Threatening