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

Model Number	N/A
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	09/03/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted past the 30 day reporting requirement as part of a retrospective review of the report that was initiated during an fda inspection.A retrospective review of the complaint record determined that this report should have been submitted as a malfunction report.In this case, no patient injury occurred; however, this may be likely to cause or contribute to a serious injury if it recurred.(b)(4).Investigation / evaluation during the course of investigation a review of the complaint history, device history record, instructions for use and a visual inspection of the returned device was conducted.The visual examination confirmed that the sheath with the check-flo valve was in a used and separated condition.Further inspection noted that the flare of the sheath was pulled out from the proximal hub.Upon further investigation, it was also found that there were wrinkles in the shaft material and the flare had some small damage.The device history record was reviewed for anomalies related to the cause for this complaint and none were observed.It should be noted that if the only device inserted in the sheath during removal was the amplatz wire guide (as stated in the customer response), then the instructions in the ifu were not followed.The root cause was determined to be product use or handling related as the user did not follow instructions/label.This mdr is being submitted past the 30 day reporting requirement as part of a retrospective review of the report that was initiated during an fda inspection.A retrospective review of the complaint record determined that this report should have been submitted as a malfunction report.In this case, no patient injury occurred; however, this may be likely to cause or contribute to a serious injury if it recurred.
Event or Problem Description
A pta sfa right side, with in stent stenosis was being conducted on the male patient with pre-existing condition of vascular disease.Information was provided that the patient has a lot of scar tissue in the left groin.The physician used a cross over approach, puncture of left cfa with a cook catheter access percutaneous entry needle, followed by placement of amplatz wire.Difficulties were experienced with placement of the kcfw sheath as scar tissue resulted in a lot of friction.The physician decided to exchange the 30cm flexor sheath for a 45cm flexor sheath and attempted to remove the kcfw 30cm sheath by pulling the valve.It was reported that there was friction and suddenly the check-flo valve separated from the flexor sheath; resulting in bleeding.The sheath was exchanged quickly for the 45cm flexor.It was reported that 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: 6289418
• Report Number: 1820334-2017-00205
• Device Sequence Number: 13657353
• Product Code: DYB
• UDI-Device Identifier: 00827002088672
• UDI-Public: (01)00827002088672(17)170814(10)5213331
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2015

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-6.0-38-30-RB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2015
• Initial Report FDA Received Date: 01/31/2017
• 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