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

Model Number N/A

Device Problem Obstruction of Flow (2423)

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

Event Date 11/16/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Occupation: unknown.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 that there was a deformity found on the ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter.The patient had a nephrostomy to drain urine from the kidney.The device was in place for a month and a half when a deformity was found on the catheter.The patient came into the emergency room and the device was removed and replaced.The device is not available for return, as it was thrown away by the facility.The patient did not experience any adverse effects due to this occurrence.

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 it was reported by (b)(6) of (b)(6) hospital located in the republic of korea that on (b)(6) 2022 a deformity was found in an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (rpn: (b)(4), lot# unknown).The device was placed in the kidney of an unknown patient for percutaneous nephrostomy (pcn) drainage.A month and half after placement, a deformity in the catheter was discovered.The patient then reported to the emergency room and the device was removed and replaced.No other adverse events were reported for this occurrence.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a visual inspection of the customer provided photos, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a photo of the complaint device was provided by the customer, and biomatter is visible on the device.The nature of the catheter deformity is unclear from the photo.Additionally, 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 for this device.Cook performed an expanded sales search of all ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheters between (b)(6) 2018 and (b)(6) 2021 and found (b)(4) different lots sold to this customer between the dates.Unfortunately, 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 device master record, 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 instructions for use [t_multi_rev5] provided with this lot contain the following precautions: "precautions ¿ activate the hydrophilic coating, if present, by wetting the catheter with sterile water or saline.For best results, keep catheter surface wet during placement.¿ catheters should be irrigated on a routine basis to ensure function.¿patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter how supplied ¿ upon removal from package, inspect the product to ensure no damage has occurred." based on limited information, cook medical has concluded 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 DAWSON-MUELLER 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: 13019704
• MDR Text Key: 284129702
• Report Number: 1820334-2021-02694
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 09/15/2022
• Supplement Dates FDA Received: 10/07/2022
• 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): Required Intervention