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 Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 04/10/2018

Event Type  Injury  

Manufacturer Narrative

(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

Catheter was successfully placed on (b)(6) 2018 for renal abscess drainage.The customer reported that the patient came back with hub separation.Due to this occurrence, the patient had to undergo procedure to replace the catheter.The catheter was placed for four days.The patient did not experience and adverse events.The device is reportedly available for return; however, as the date of this report, no device has been yet received for evaluation.

Manufacturer Narrative

Corrected data: d6: implant date: (b)(6) 2018;explant date:(b)(6) 2018 h6: patient codes: 3191 additional procedure to replace drainage catheter investigation - evaluation.A review of the documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications and visual inspection/dimensional verification of the returned device was conducted during the investigation.The visual inspection of the returned device confirmed one 10.2french mac-loc catheter in two separate pieces, the catheter tubing comprising one piece and the mac-loc hub, cap, and stopcock comprising the second piece.The flare appeared out of round, shallow, and has a lip.Due to the compression of the flare within the cap and potential damage upon removal, it cannot be determined whether the flare was manufactured out of specifications.Biomatter was noted on the device.Particular discoloration was noted near the threads.The catheter shaft outer diameter, connector cap inner diameter, mac-loc hub distal inner diameter, and number of adapter threads showing were all found to be within manufacturing specifications.A twist test revealed that the cap was securely attached to the proximal assembly.Upon removing the connector cap, the suture string was revealed wound in the threads.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.We will continue to monitor for similar complaints and are currently investigating this failure mode.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 new event description information to report at this time.

• 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: 7479752
• MDR Text Key: 107119048
• Report Number: 1820334-2018-01153
• 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: 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?: No
• Device Operator: Health Professional
• Device Catalogue Number: ULT10.2-38-25-P-6S-CLM-RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Date Manufacturer Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention