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 Complete Blockage (1094)

Patient Problem No Code Available (3191)

Event Date 06/18/2019

Event Type  Injury  

Manufacturer Narrative

Patient code: (b)(4).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 female patient required an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter used for nephrostomy drainage.The device was placed on (b)(6) 2019.The operator reported that on (b)(6) 2019 the catheter became blocked and required removal.On removal, the operator noted the tip was blocked and they were unable to pass a guide wire through catheter.Additionally, the catheter did not want to unlock easily for removal.Another similar device was placed and the procedure was completed successfully.No other adverse effects were reported for this incident.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.H6 - additional methods code: device not returned (4114).Investigation ¿ evaluation.It was reported that the catheter within a ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was occluded at the tip.The device was placed on (b)(6) 2019.On (b)(6) 2019 the physician was attempting to advance a wire through the catheter for removal and replacement, but found the it could not be advanced due to the occlusion.This incident was reported by (b)(6), in the united kingdom, on (b)(6) 2020.The device was removed, and another was placed to successfully complete the procedure.No adverse effects were reported.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection, were conducted during the investigation.The complainant did not return the complaint device to cook for investigation.However, a powerpoint presentation with photos of the failure was provided.From analysis of the photos, a wire guide was unable to be passed through the pigtail, and it was confirmed that an excess amount of biomatter was within the distal tip, occluding all of the sideports and distal tip.No further analysis was able to be completed due to the device not being returned.At this time however, cook cannot conclude that the device was manufactured out of specification.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: warnings: ¿if a catheter has become malpositioned or if drainage ceases, the catheter should be promptly exchanged or removed.¿ precautions: ¿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.¿ the device history record (dhr) was also reviewed.The dhr for the complaint lot and related subassemblies records one relevant non-conformance for ¿shaft, difficult to wire¿ (qty.1, scrapped).However all nonconforming product was scrapped, and the product goes through a 100% inspection for the reported nonconformance.A database search for complaints on the reported lot found no additional complaints have been reported from the field.At this time, there is no evidence suggesting that nonconforming product from this lot exists in house or in the field.Additional information regarding the maintenance protocol and items injected through catheter was received from the customer stating, ¿no specific maintenance protocol, usually flush catheter at insertion and a contrast injection at the end of placement.¿ the instructions for use (ifu) supplied with the device states, ¿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.¿ based on the information provided, review of the customer photos, and the results of the investigation it was concluded that a maintenance issue and patient condition contributed to this incident.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: 9667033
• MDR Text Key: 185292717
• Report Number: 1820334-2020-00279
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095014
• UDI-Public: (01)00827002095014(17)210920(10)9175078
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

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 Expiration Date: 09/20/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: 9175078
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention