MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Code Available (3191)

Event Date 06/14/2019

Event Type  Injury  

Manufacturer Narrative

Suspect medical device: product information currently unavailable.Occupation: unknown.Pma/510(k) #: product information unavailable.(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 patient required three ultrathane mac-loc locking loop multipurpose drainage catheter replacements due to leaking.The replacements are described below: the patient had 10 fr bilateral nephrostomy tubes implanted on (b)(6) 2019.On (b)(6) 2019, the patient returned due to leaking on the right side.The nephrostomy tubes on both sides were exchanged for cook 12 fr catheters on (b)(6) 2019 to keep the exchange schedule the same for both sides.This event is recorded under patient identifier (b)(6).On (b)(6) 2019, the patient returned due to leakage from the drain on the right side.Both drains were exchanged again for drains of the same type and size.This event is recorded under patient identifier (b)(6).On (b)(6) 2019, after the catheter exchange, the left drain was found leaking from the hub at the connection with the drainage bag.The drainage bag was replaced but the leaking continued.The 12 fr drain was then exchanged again without further incident.The drain was found to be cracked at the hub distal end.This event is recorded under patient identifier (b)(6).No other adverse effects were reported for this incident.

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 a review of the complaint history, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a similar product experiencing the same failure mode in another complaint (captured under medwatch report # 1820334-2019-01101) was examined.The physical examination of the similar complaint device found that a leak was present between the connector cap and hub, but the device was confirmed to be measured within specification.The investigation under medwatch report # 1820334-2019-01101 could not establish a definitive root cause of the failure.Due to the similarities between the devices and the failure modes, it is likely that the two events have a similar cause.Additionally, a document based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Based on the information provided, no returned product and the results of the investigation, a definitive cause could not be established.Appropriate measures have been taken to address this failure mode.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.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8830776
• MDR Text Key: 152325769
• Report Number: 1820334-2019-01808
• Device Sequence Number: 1
• Product Code: DQO
• 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
• Report Date: 09/09/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 07/26/2019
• Supplement Dates Manufacturer Received: 09/06/2019
• Supplement Dates FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 73