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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device 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
International customer reported that the physician was placing a central venous catheter through a right subclavian approach.The attending physician began to remove the guide wire through the catheter at which time the guide wire became "loose" along the mid to proximal portion of the wire.The customer indicated that an additional recannulation procedure was performed to complete the implantation of the central venous catheter.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, specifications, quality control and visual inspection of the returned device was conducted during the investigation.One double ended wire guide was returned for evaluation.Upon examination of the returned product, the proximal solder joint between the mandril and safety wire cannot be located.There is some discoloration/possible remnants of solder or flux in the area where solder should be.Biomatter is also present on the entire device.The wire's coil is intact on both the proximal and distal ends, but unraveled in the middle of the guide.Further visual examination discovered the weld connection opposite of the j-curve to have separated from the safety wire, resulting in coil elongation.The weld connection was found to be in tact.A further examination of the length of coil that was not elongated measured approximately 14.0 cm.The total length of elongated coil measured approximately 23.9cm.The safety wire and/or mandril wire exited the coil.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows 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, examination of the returned device and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.

• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK UROLOGICAL INC; 1100 west morgan st; spencer IN 47460
• MDR Report Key: 6301499
• Report Number: 1820334-2017-00154
• Device Sequence Number: 736181
• Product Code: FOZ
• UDI-Device Identifier: 00827002536029
• UDI-Public: (01)00827002536029(17)181209(10)6905311
• 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): 06/07/2017

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?: No
• 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: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention