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	Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/23/2017
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, when the cook spectrum minocycline/rifampin impregnated double lumen central venous catheter was being introduced over the guidewire following the dilation of the access site and the subsequent insertion of the guidewire, the catheter could not advance over the guidewire.Approximately 10 cm of length of the proximal end portion of the device did not advance.The procedure was a central venous catheter cannulation of the right internal jugular vein.The product was returned for evaluation; however, as of the date of this report, the investigation is still pending.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation, and no issues were found related to the reported issue.The visual inspection of the returned device confirmed that the wire guide outer diameter and central venous catheter endhole diameter both measured within specification, and the wire passed freely through the central venous catheter via the red port, as expected.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 showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the risk assessment, no further action is required.After further review of the complaint record, it has been determined this event is not reportable and therefore, reported in error.The patient did not experience serious injury, nor was surgical/medical intervention required to preclude serious injury or permanent impairment.Additionally, if this malfunction were to recur, the potential for serious injury is remote, as a detailed search of available risk documents has not indicated a heightened patient risk as a result of the reported failure mode.Furthermore, a detailed search of the complaint database has not revealed the occurrence of any previous precedent setting event.The complaint will be further processed as a non-reportable complaint.

• 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: 7107573
• Report Number: 1820334-2017-04363
• Device Sequence Number: 1290203
• Product Code: FOZ
• UDI-Device Identifier: 00827002536012
• UDI-Public: (01)00827002536012(17)200322(10)7976751
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K033843
• 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): 02/13/2018

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-P
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1