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 Break (1069)

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

Event Date 08/31/2017

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 international customer reported that, while using the ultrathane mac-loc locking loop biliary drainage catheter inside the patient body, the wire broke.The operator of the device was reportedly attempting to "form the loop inside the patient body." it is unknown if the term "wire" is referring to the suture loop included with the device, or if it is referencing a guide wire that was employed in conjunction with the catheter; additional information has been requested from the customer.The circumstances surrounding the usage and handling of the device are unknown.The product will reportedly not be returned for evaluation.

Manufacturer Narrative

A review of complaint history, device history record, manufacturing instructions and quality control data was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device history record was reviewed and one nonconformance from the same lot was noted, however this was unrelated to the reported mode of failure.This complaint is the only reported complaint associated to the complaint lot number 7704942.Based on the provided information, no product returned and the investigation, a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and 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: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6864477
• MDR Text Key: 86115500
• Report Number: 1820334-2017-02894
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)200224(10)7704942
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2017
• Date Device Manufactured: 02/24/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1