MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Gas/Air Leak (2946)

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

Event Date 01/28/2022

Event Type  malfunction  

Event Description

It was reported an unknown patient underwent placement of an ultrathane mac-loc locking loop multipurpose drainage catheter.Immediately after placement, the physician flushed the catheter and an air leak was noted.The catheter was cut in order to release the pigtail and the device was removed from the patient.The user reported a hole was discovered near the catheter hub.A second, similar catheter was placed to complete the procedure.As reported, the patient did not experience any adverse effects or require an additional procedure as a result of this incident.

Manufacturer Narrative

Lot number: a possible lot number was provided as 14042218.Occupation: ir supervisor.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 an unknown patient underwent placement of an ultrathane mac-loc locking loop multipurpose drainage catheter.Immediately after placement, the physician flushed the catheter and an air leak was noted.The catheter was cut in order to release the pigtail and the device was removed from the patient.The user reported a hole was discovered near the catheter hub.A second, similar catheter was placed to complete the procedure.As reported, the patient did not experience any adverse effects or require an additional procedure as a result of this incident.

Manufacturer Narrative

Lot number: a possible lot number was provided as 14042218.Occupation: ir supervisor.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

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

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation on 28jan2022, (b)(6) medical received a complaint from ms.(b)(6), a representative at the (b)(6)center, located in the city of (b)(6).It was reported that when the physician went to flush the ultrathane mac-loc locking loop multipurpose drainage catheter (rpn; ult8.5-38-25-p-6s-clm-rh; lot: unknown), it was discovered that air leaked.As a result, the shaft was cut in order to release the pigtail curve and remove from the patient.A hole was observed near the hub of the catheter.Another 8.5 fr.Multipurpose catheter was used.The patient did not experience any adverse effects or require an additional procedure as a result of this incident.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures of the 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.In response to this incident, 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.The customer did not provide a lot number.Therefore, cook performed an expanded sales search for the reported device, shipped to this customer between 28jan2018 and 28jan2022.Cook medical reviewed sales records and was unable to identify the complaint lot.As a result, cook was unable to review the device history record.Based on the dmr, dhr, device failure analysis, and design history file review there is no indication the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Cook also reviewed product labeling.The current instructions for use [ifu__multi_rev5] state the following: "precautions-patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter." based on the information provided, no returned device, and the results of the investigation, it was determined the root cause of this event is related to component failure, without any evidence of design or manufacturing issue.The user did not identify any damage during initial placement.It is possible that the catheter underwent excessive force or tension while placed in the patient.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 MAC-LOC LOCKING LOOP 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: 13549579
• MDR Text Key: 286140747
• Report Number: 1820334-2022-00245
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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-CLM-RH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 09/29/2022
• Supplement Dates FDA Received: 10/20/2022
• 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