MAUDE Adverse Event Report: COOK INC FLEXOR INTRODUCER SHEATH; DYB INTRODUCER, CATHETER

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	02/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
During an unknown procedure on a patient of unknown age and gender the side port came off of the introducer during injecting.The patient lost an unknown amount of blood but did not require a transfusion.The physician was able to replace the product and complete the procedure with no further complications.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, instructions for use (ifu), 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 contraindications, warning, precautions and instructions for use.The visual inspection of the returned device reveals that glue residue is visible around the entire circumference of the tube.This would suggest that the device was manufactured properly and that it saw excessive force in use.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 it is feasible to suggest that the separation could have been caused by the device experiencing high internal pressures or experiencing high forces on the connecting tube/proximal fitting glue joint.However, with the current information available, a definite root cause cannot be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
During an unknown procedure on a patient of unknown age and gender the side port came off of the introducer during injecting.The patient lost an unknown amount of blood but did not require a transfusion.The physician was able to replace the product and complete the procedure with no further complications.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: FLEXOR INTRODUCER SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5467309
• Report Number: 1820334-2016-00086
• Device Sequence Number: 562613
• Product Code: DYB
• UDI-Device Identifier: 00827002078574
• UDI-Public: (01)00827002078574(17)181020(10)6301256
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2016

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: KCFW-9.0-38-RB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/02/2016
• Device Age: 4 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/29/2016
• Supplement Report FDA Received Date: 11/28/2016
• 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