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 Codes	Bent (1059); Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: 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
The international customer reported that, after a successful insertion of the cook spectrum minocycline/rifampin impregnated double lumen central venous catheter into the right internal jugular vein of the patient over the guidewire, the guidewire began to kink and bend when the operator attempted to remove it from the rest of the assembly, per procedure.When the usage of the device failed, the operator removed and replaced the line with a teleflex arrow central venous catheter set.The difficulties with catheter sets reportedly occur usually in difficult cases, but have been also occurred regardless of procedure difficulty and the skill of the operator.The device has been received for evaluation; however, as of the date of this report, the investigation is pending.The specific circumstances surrounding the usage and handling of the device are not known.
Additional Manufacturer Narrative
Additional information: device evaluated by mfr.Investigation - evaluation: a review of dimensional verification, complaint history, device history record, instructions for use (ifu), manufacturing instructions, specifications, quality control data, and visual inspection of the returned device was conducted during the investigation.One hdoc wire guide was returned.The wire guide was kinked approximately 32 cm from the proximal end.Measurements of the component in question were performed and it was found that the device was manufactured to specification.An analysis of the returned wire guide did not reveal any evidence that the component was manufactured out of specifications.A document-based investigation was performed.Review of the device history record confirmed that no nonconformance¿s were recorded.The device history record for the component parts were reviewed and four nonconformances were noted; however, all were discarded prior to further processing.A search of our complaint records indicates that there are two additional complaints associated to the complaint lot number at the time of investigation.Both of these complaints are from the same customer.Based on the provided information, inspection of returned product, and the investigation results, a definitive root cause cannot be established or reported at this time.Per the risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 6878363
• Report Number: 1820334-2017-02942
• Device Sequence Number: 712468
• 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,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-UDLM-801J-ABRM-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1