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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, or unavailable.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
A flexor raabe guiding sheath was used in a venous stenting procedure in a femoral vein in the leg, via contralateral approach.It was reported that when removing the catheter, it damaged the valves on the sheath and it "came a part." it is believed that the catheter pulled the diaphragm when it was removed, causing the sheath damage.The procedure was able to be completed successfully.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
This is one of two sheaths used in the procedure.The other sheath has been reported under mw 1820334-2017-03198.Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.A flexor raabe guiding sheath was returned for investigation.The sheath was returned with the silicone disc protruding through the check-flo cap.The check-flo assembly was disassembled to further examine the disc.The disc was oriented correctly within the check-flo.No tears were visible, and the disc was slit edge to edge.The proximal hole of the check-flo cap accepted a 0.151" pin gauge.The silicone disk measured 0.354" from flat edge to flat edge and 0.410" from round edge to round edge.The ivus catheter was unable to advance through the proximal end of the device.The ivus catheter was able to fully advance distally through the sheath.However, resistance was encountered during advancement through the silicone disc.The inner diameter (i.D.) of the sheath was measured to be 0.113" by passing a 0.112" checker wire through it.The outer diameter (o.D) of the ivus catheter was measured to be 0.113" at its widest section in the distal end.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.As the outer diameter of the widest section of the volcano ivus catheter measures the same as the inner diameter of the raabe guiding sheath tubing, it is possible that the user experienced resistance during removal of the ivus catheter which led to the silicone disk getting dislodged and protruding out of the check-flo cap hole.The root cause has been determined to be related to user technique.Per the ifu: "the maximum diameter of the instrument or catheter to be introduced should be determined to ensure its passage through the introducer.All instruments or catheters used with this product should move freely through the valve and sheath.Damage to the valve/introducer may result when the fit is tight." per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: FLEXOR RAABE GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6878703
• Report Number: 1820334-2017-03197
• Device Sequence Number: 13477548
• Product Code: DYB
• UDI-Device Identifier: 00827002122420
• UDI-Public: (01)00827002122420(17)190208(10)6719854
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KCFW-8.0-38-55-RB-RAABE
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1