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

Model Number N/A

Device Problems Bent (1059); Kinked (1339)

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

Event Date 09/05/2017

Event Type  malfunction  

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 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.

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
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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: 6878363
• MDR Text Key: 87861466
• Report Number: 1820334-2017-02942
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002508170
• UDI-Public: (01)00827002508170(17)200201(10)NS7839146
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K081113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• 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: C-UDLM-801J-ABRM-HC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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