MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Model Number N/A

Device Problem Material Separation (1562)

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

Event Date 10/10/2016

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.No known impact or consequence to patient were reported.Material separation is not labeled.The event is currently under investigation.

Event Description

It was reported that after a percutaneous nephrostomy tube exchange (using a biliary drain) procedure, the post-op nurse noticed an issue with an int/ext biliary drain, where the soft catheter part became detached from the hard plastic hub, after placement.Luckily the biliary drain was being used as a makeshift neph-u and the pigtail was not engaged.The post-op nurse was able to disassemble the locking hub at the patient's bedside and re-assemble the catheter without having to bring the patient back for a replacement." the catheter remained inside the patient, as it was intended.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation - evaluation: a review of the drawings, documentation, manufacturing instructions, and quality control was conducted during the investigation.A search of other complaints with the same lot number could not be completed as the lot number was not provided and unavailable.The device history record was not reviewed as the lot number was not provided and unavailable.A review of the product was not performed as the device was not returned for evaluation.Based upon the fact that the customer indicated that the catheter tubing separated from the proximal fittings and that they were able to disassemble, reassemble the catheter it is not likely that the catheter tubing separated, and thus more likely that the tubing/flare pulled out of the cap/proximal fitting.Inadequate flare size is a potential cause of this issue, but excessive force could also contribute to the reported issue.Without return of the complaint device or photos of the device to confirm the exact failure mode and to measure flare size, the root cause remains inconclusive.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
• Type of Device: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6092436
• MDR Text Key: 59589770
• Report Number: 1820334-2016-01260
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT12.0-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 72