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 Obstruction of Flow (2423)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event: event occurred approx.Every 8 weeks for the past 5 years.Pma/510(k) #: exempt.(b)(4).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 male patient required an ultrathane mac-loc locking loop multipurpose drainage catheter for a nephrostomy tube exchange.It was noted that the patient required a tube exchange due to "encrustation" every 8 weeks for the last 5 years.The operator stated the patient used a drill bit to unclog it.No other adverse effects were reported for this incident.

Manufacturer Narrative

Additional method code: device not returned (4114).Investigation / evaluation: nhs-new hospital complex in canada informed cook of an incident involving an ultrathane multi-purpose drainage.On (b)(6) 2020, the nephroureterectomy tubes were encrusting and needed to be changed as soon as 9 days.This complaint was reported under medwatch report#: 1820334-2020-01368.Cook was later informed that this same patient has required tube exchanged due to encrusting for approximately every 8 weeks over the last five years.This complaint is captured under this report.The patient has been compliant with regulatory flushing the tubes.No unintended section of the device remained inside the patient¿s body and there have been no adverse effects to the patient due to these occurrences.However, the patient requires more frequent tube exchanges due to the encrustation.From a global sales shipment report, cook was able to narrow down the rpn this complaint pertains to which is a ultrathane mac-loc locking loop multipurpose drainage catheter.Therefore, the investigation was completed on this device.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control 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.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 malposition 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.¿ in response to this incident, cook could not complete a review of the device history record (dhr) due to lack of lot information from the user facility.A global sales shipment report was conducted from 01jan2012 through 23jun2020 for possible devices.The customer bought (b)(4) lots of only one device rpn meeting the description provided.A complaint search was conducted on these (b)(4) lots and no complaints were found.A nonconformance search was conducted on these (b)(4) lots and no related nonconformances were found.There is no evidence suggesting nonconforming product from the affected lot exists in house or in the field.A definitive conclusion could not be determined why the nephroureterectomy tubes were encrusting.Findings of this investigation revealed no evidence to suggest the device was manufactured out of specification.It was reported that the customer was regularly flushing the tubes.It is possible the patient¿s diet or anatomy contributed to the failure.Based on the information provided, no returned product and the results of the investigation, the investigation conclusion for this complaint is cause traced to an adverse event related to the patient¿s condition.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: 10434599
• MDR Text Key: 204572953
• Report Number: 1820334-2020-01533
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

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 Model Number: N/A
• Device Catalogue Number: ULT14.0-38-60-P-6S-CLM-RH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/20/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR