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 Moisture or Humidity Problem (2986)

Patient Problem No Patient Involvement (2645)

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The customer reported that, when the ultrathane mac-loc locking loop biliary drainage catheter was opened during the preparation stage of the procedure, water was observed to be coming out of the retention clip of the device.The customer confirmed that this was prior to the usage of the device, and that no patient contact was made; accordingly, there were no adverse events which occurred.The product has been returned for evaluation; the investigation is currently pending.

Manufacturer Narrative

Corrected information: device evaluated for mfr.Investigation summary: a review of the functional test, documentation, device history record, dimensional verification, complaint history, drawing, instructions for use, quality control, manufacturing investigation and a visual inspection of the returned device were conducted during the investigation.The catheter was returned in a used condition with no obvious biomatter present.The tubing was not able to twist or tug within the cap.The cap was not able to untwist from the mac-loc.The mac-loc was in the unlocked position.No cracks were visible on the proximal assembly.There were 2 threads visible between the mac-loc and cap.Hemostats were used to occlude the catheter tubing in order to pressurize the proximal assembly.Water immediately leaked from the mac-loc.The mac-loc was then pushed into the locked position, and the proximal assembly was pressurized again.A pressure of 8.25psi was held for approximately 2 min without any water drops forming or falling from the proximal assembly.Since the device was returned with the mac-loc in the unlocked position, it is likely that the water the customer observed coming out of the retention clip was due to the mac-loc being unlocked.The mac-loc is not intended to hold a seal when in the unlocked position.Additionally, the device never made patient contact, so it is unlikely that fluid leaking at the time of the event would clog the leak.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record found no non-conformances associated with the complaint device lot number.It should be noted there were no other reported complaints for this lot number.There is no evidence to suggest all items in the lot or similar devices in house are nonconforming/defective.Based on the information provided, the examination of the returned product, and the results of our investigation, a root cause was therefore identified as likely user error.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6862070
• MDR Text Key: 86004378
• Report Number: 1820334-2017-02891
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094987
• UDI-Public: (01)00827002094987(17)200502(10)7879515
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/13/2017
• Supplement Dates Manufacturer Received: 11/20/2017
• Supplement Dates FDA Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2017
• 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