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 Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Device available for evaluation: unknown.Occupation: (b)(6).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 of undisclosed age and gender required an ultrathane mac-loc locking loop multipurpose drainage catheter for a nephrostomy tube procedure.The device was determined to be leaking at the "clamp site." a competitors device was used to replace the leaking tube.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

Additional information received 16dec2020 stated the procedure was a nephrostomy procedure.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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

Investigation - evaluation (b)(6) medical center (united states) informed cook that on (b)(6)2020, the hub on a ult10.2-38-25-p-6s-clm-rh (ultrathane mac-loc locking loop multipurpose drainage catheter) from lot 13164317 leaked.The user was placing the catheter and noticed leakage under the mac-loc lever.They used a new catheter to successfully complete the procedure.A review of the complaint history, device history record (dhr), instructions for use (ifu), and quality control, as well as a visual inspection and functional test of the returned device, was conducted during the investigation.One used device cut in two pieces was returned to cook for evaluation.A functional leak test confirmed leakage under the mac-loc lever.Disassembly of the lever revealed the silicone insert was present.Further inspection found a crack in the mac-loc body under the lever.Cook has concluded that the device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (13164317) and related mac-loc subassembly lots revealed no recorded non-conformances.A database search did not identify any other events associated with the reported device lot.The torque driver used to assemble the proximal fitting passed calibration both before and after the lot was produced.Given this information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The instructions for use [t_multi_rev5] supplied with the device states the following in consideration of the reported failure mode: "catheter placement 3.For locking loop catheters, lock the catheter in place using appropriate technique for the locking mechanism type, as described below.For mac-loc locking loop mechanism a.Stabilize the mac-loc catheter hub assembly with one hand and pull back on the drawstring to form the distal catheter loop configuration.B.While maintaining traction on the drawstring, push the locking cam lever down until a distinct "snap" is felt.The distal loop of the catheter is now locked into position.C.Trim off the excess drawstring." based on the information provided, inspection of the returned device, and the results of the investigation, a definitive root cause for this event was traced to component failure unrelated to a deficiency in manufacturing/device design.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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.

Event Description

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

• 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
• MDR Report Key: 11013984
• MDR Text Key: 223796120
• Report Number: 1820334-2020-02307
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2021

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 Expiration Date: 04/29/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-25-P-6S-CLM-RH
• Device Lot Number: 13164317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 12/16/2020; 04/07/2021
• Supplement Dates FDA Received: 12/28/2020; 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 156