MAUDE Adverse Event Report: COOK INC; 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	02/12/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
International customer reported that a patient underwent placement of a spectrum minocycline/rifampin impregnated double lumen central venous catheter for an unspecified indication.The device was implanted into the right subclavian vein.The guidewire began to kink and bend while the operator attempted to remove the guidewire following successful placement of the catheter.A portion of the wire allegedly came loose in the mid to proximal portion.The site was recannulated and the procedure completed.There are no reported adverse patient consequences.There are no reports of any unintended sections of device retained within the patient.The specific handling, conditions and circumstances surrounding the event are not known.The instructions for use (ifu) that accompany the device state:" if resistance is encountered during wire guide insertion, do not force wire guide.Withdrawal of wire guide through needle should be avoided; breakage may result." the device was returned for evaluation.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the device history record, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the wire guide was inside the catheter.The wire was pulled from the proximal end, but it lodged near the distal end.The wire was ultimately able to be removed by pulling from the distal end.There was a mass of bio-matter that was attached approximately 15.6 cm from the distal tip.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.It is feasible that the wire guide encountered bio matter during catheter placement which caused it to become stuck in the distal end and prevented the removal while pulling from the proximal end.We will continue to monitor for similar complaints.Per the risk assessment, no further action is required.

• 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: 6406272
• Report Number: 1820334-2017-00392
• Device Sequence Number: 13532420
• Product Code: FOZ
• UDI-Device Identifier: 00827002536029
• UDI-Public: (01)00827002536029(17)171201(10)5614177
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2017

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-RSC-ABRM-HC-P
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2017
• Supplement Report FDA Received Date: 04/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1