MAUDE Adverse Event Report: COOK INC COOK SPECTRUM; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device brand: cook spectrum minocycline/rifampin impregnated double lumen central venous catheter.(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 or Problem Description
International customer reported that a patient was undergoing placement of a cook spectrum minocycline/rifampin impregnated double lumen central venous catheter for an unspecified indication.The central venous catheter was inserted successfully into the right internal jugular vein of the patient over the guidewire in an intermidiate stage of the procedure.The guide wire kinked and uncoiled when the physician then attempted to remove the assembly at the termination of the procedure.There are no reported adverse patient consequences related to this event.The device is available for evaluation.
Additional Manufacturer Narrative
Corrected data: device evaluated by mfg - answer changed from no to yes.Investigation - evaluation: a review of dimensional verification, device history record, documentation, ifu, manufacturing instructions, specifications, and quality control data was conducted during the investigation.Visual inspection of the returned device was performed.The wire guide coil was unraveled, starting approximately 530 mm from the proximal end of the wire guide.The outer diameter of the coil was measured, and found to be within specifications.It is possible based on the provided information that the root cause of this event is procedure related, however we do not have enough evidence to identify a definitive root cause at this time.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconforming events which could contribute to this failure mode.A search of our complaint records indicates that there are two other complaints on the lot number at the time of investigation and both are from the same customer as this complaint.Based on the provided information, inspection of returned product, and the investigation, a definitive root cause cannot be established or reported at this time.An analysis of the returned wire guide did not reveal any evidence that the component was manufactured out of specifications.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: COOK SPECTRUM
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6773555
• Report Number: 1820334-2017-02238
• Device Sequence Number: 13764832
• Product Code: FOZ
• UDI-Device Identifier: 00827002508170
• UDI-Public: (01)00827002508170(17)200201(10)NS7839146
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K081113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2017

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
• Operator of Device: No Information
• Device Model Number: N/A
• Device Catalogue Number: C-UDLM-801J-ABRM-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/24/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1