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

Model Number	N/A
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
A patient of unknown gender and age was undergoing a tips procedure.Utilizing intermittent fluoroscopic guidance, the sheath was advanced into the right atrium.At this point it was noted that the sheath did not have a radiopaque band to mark where the sheath ended.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable or unchanged.Investigation- a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions (mi), quality control (qc) and a visual inspection of the complaint device was conducted for the purpose of this investigation.One used product was returned for investigation.During a visual inspection of the returned complaint device, it was confirmed that the radiopaque band was missing from the distal tip of the sheath.The tip did not appear to be damaged and the sheath was measured, which indicated that the marker band nor tip of the sheath had separated.Destructive testing was then conducted to remove the sheath from the hub.When this was done, it was found that the radiopaque marker band was located on the proximal end of the sheath, thus confirming the device was not manufactured to specification.There is no reported injury to the patient.A search revealed this complaint to be the only reported complaint associated to the complaint lot number 6478487.Instructions are in place to examine the device for any nonconformities.A quality engineer risk assessment was created to evaluate the risk of this failure mode; based on the results of the analysis, no further risk reduction is required.We will continue to monitor for similar complaints.
Event or Problem Description
A patient of unknown gender and age was undergoing a tips procedure.Utilizing intermittent fluoroscopic guidance, the sheath was advanced into the right atrium.At this point it was noted that the sheath did not have a radiopaque band to mark where the sheath ended.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: FLEXOR GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5573157
• Report Number: 1820334-2016-00227
• Device Sequence Number: 363035
• Product Code: DYB
• UDI-Device Identifier: 00827002322332
• UDI-Public: (01)00827002322332(17)181223(10)6478487
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2016

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-10.0-38-40-RB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2016
• Supplement Report FDA Received Date: 01/03/2017
• 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: Other