MAUDE Adverse Event Report: COOK INC TRIFORCE¿ PERIPHERAL CROSSING SET; KRA CATHETER, CONTINUOUS FLUSH

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
The device broke and wasn't even being touched during crossing a venous occlusion procedure.When the user went to remove it from the patient's access site, the device came apart between the hemostatic valve and sheath.No instruments were used to remove the device.Information was provided that you can see the wire.The white connector still has the a piece of catheter in it.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Initial was filed within the 30 day time frame regardless of corrected date.Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, trends, quality control and visual inspection of the returned device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as warnings, precautions, and instructions for use.Work instructions for flaring, "flare should be free of splits, nicks, pits, holes, kinks, and creases.Flare inside diameter should be unobstructed and round.Inside diameter should be free of debris, material flaps, strands, and protruding wires." the visual inspection of the returned device reported that the check-flo assembly with the flare still inside the connector cap, was separated from the rest of the sheath.The proximal end of the sheath tubing contained exposed, stretched coiling.The tubing was measured to be 89.6 cm.The complaint device was returned therefore, an investigation evaluation was 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, there is no evidence to suggest that the device was not manufactured to specification.The device broke and wasn't even being touched during crossing a venous occlusion procedure.When the user went to remove it from the patient's access site, the device came apart.At this time, with the information known, a definite root cause cannot be determined.However, it is possible that during removal of the sheath, a force greater than the device's intended design had been applied, thus resulting in the observed material separation.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
The device broke and wasn't even being touched while crossing a venous occlusion procedure.When the user went to remove it from the patient's access site, the device came apart between the hemostatic valve and sheath.No instruments were used to remove the device.Information was provided that you can see the wire.The white connector still has the a piece of catheter in it.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: TRIFORCE¿ PERIPHERAL CROSSING SET
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5865518
• Report Number: 1820334-2016-00746
• Device Sequence Number: 1509205
• Product Code: KRA
• UDI-Device Identifier: 00827002564176
• UDI-Public: (01)00827002564176(17)190609(10)7001925
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K111263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2016

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: KCXS-5.0-35-100-RB-0/DAV-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2016
• Supplement Report FDA Received Date: 11/08/2016
• 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: Other