MAUDE Adverse Event Report: COOK INC ROTHBARTH UNI-FLO INFUSION CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problems Fracture (1260); Kinked (1339)

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

Event Date 08/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

A rothbarth uni-flo infusion catheter was used in an angiography catheter placement procedure on a (b)(6) old patient, which took approximately two hours.It was reported that, the nurse was preparing to inject medication for thrombolysis and found a crack on the connector (hub) of the catheter.The physician inserted a wire guide along the catheter and withdrew it.A new catheter was used to complete the procedure.A section of the device did not remain inside the patient¿s body.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

Additional information: kinks were noticed on the rothbarth uni-flo infusion catheter shaft upon device receipt.Corrected information: report source.Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, documentation, instructions for use (ifu), trends, quality control, and visual inspection of the returned device was conducted during the investigation.One rothbarth uni-flo infusion catheter was returned for investigation.Two kinks were noted in the catheter shaft near the proximal end.A compression was noted at 16.8 centimeters (cm), and 17.7 cm from the proximal end.No marker bands were present.The distal tip is angled with an open lumen.The hub is cracked 6.0 millimeters (mm) in length starting from the proximal end of the hub running parallel to the catheter.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows one nonconforming event that could contribute to this failure mode.The affected parts were scrapped prior to proceeding with the work order.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined; however, shipping/handling of the device and/or excessive torque on the hub could have contributed to the device failure.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• Brand Name: ROTHBARTH UNI-FLO INFUSION CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 6809809
• MDR Text Key: 83237109
• Report Number: 1820334-2017-02696
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002082182
• UDI-Public: (01)00827002082182(17)200127(10)7602219
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2017

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: N5.0-35-100-P-16S-0-RIS-16.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 08/22/2017
• Supplement Dates Manufacturer Received: 11/21/2017
• Supplement Dates FDA Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2017
• 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
• Patient Age: 56 YR
• Patient Weight: 63