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

Catalog Number	KCFW-10.0-38-80-RB
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
It was reported that during an inferior vena cava (ivc) filter removal case, it was quite difficult to withdraw the filter within the sheath.The scrub nurse holding the sheath said that it felt like something was dragging.The filter and 15 mm snare retrieval system all came out, but when the sheath was removed, and the doctor was holding pressure, there was a white string/fibre sticking out the access site.This was removed and the patient was stable.After achieving hemostasis, the patient was sent to day surgery for post procedure care, prior to being discharged that afternoon.No part of the device remained inside the patient.The patient did not require any additional procedures nor 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: 6563311
• Report Number: 1820334-2017-01119
• Device Sequence Number: 13779413
• Product Code: DYB
• UDI-Device Identifier: 00827002130333
• UDI-Public: (01)00827002130333(17)180729(10)6074493
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2017

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 Catalogue Number: KCFW-10.0-38-80-RB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 05/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR