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

Catalog Number ULT10.2-38-25-P-6S-CLM-RH

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

(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

A ultrathane mac-loc locking loop multipurpose drainage catheter was placed for nephrostomy drain.The customer reported that patient noticed a wet feeling and the hub hanging.The hub fell off the catheter.The catheter was removed.The catheter was placed for one week.The patient did not experience and adverse events.The product has been received for evaluation; however, as of the date of this report, the investigation is still pending.

Manufacturer Narrative

Additional information: it should be noted that the catheter was inserted into the right posterior flank area, placed in the patient's back and had been activated using saline.Additionally, the patient's anatomy was reportedly "normal" and the patient outcome was "good".Investigation - evaluation: a review of the documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications and visual inspection/dimensional verification of the device was conducted during the investigation.The visual inspection of the returned device confirmed one 10.2 french mac-loc catheter in a used condition.The device was returned in two pieces.The first piece is comprised of the mac-loc hub and the connector cap.The second piece is comprised of approximately 32cm of catheter tubing from the proximal flare to the distal pigtail curl.Biomatter was present on the device, but no surface damage.A discoloration was noted in the threads of the hub.The flare had a lip and appeared lopsided.Its diameter measured at approximately 0.250".Due to the compression of the flare in the cap and potential damage upon removal, it cannot be determined if the flare was manufactured out of specification.A twist test was conducted revealing that the connector cap was secure on the proximal hub.The catheter shaft outer diameter, connector cap inner diameter, mac-loc hub distal inner diameter, and number of adapter threads were all found to be within manufacturing specifications.The lot number of the device is not known; accordingly, a review of the device history record and complaint lot search could not be conducted.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Appropriate measures have been initiated to address this failure mode.The appropriate personnel have been notified, and this failure mode will continue to be trended.Per the quality engineering risk assessment no further action is required.

• 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: 7479008
• MDR Text Key: 107074610
• Report Number: 1820334-2018-01151
• 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
• Type of Report: Initial,Followup
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ULT10.2-38-25-P-6S-CLM-RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Date Manufacturer Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1