MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	G56279
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number: pre-amendment.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, the valve of a flexor high-flex ansel guiding sheath leaked blood during an unspecified patient procedure.It was replaced with a second flexor high-flex ansel guiding sheath which also leaked resulting in "important" blood loss.Blood loss was not quantified, however.No medical intervention has been reported.Additional information regarding event details, patient anatomy and outcome has been requested, but not provided at this time.
Additional Manufacturer Narrative
Investigation/evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications and, quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A review of the lot subassemblies identified one non-conformance which could contribute to this event; however, all non-conforming product was scrapped.A complaint history search revealed that there were no other reported complaints for this lot number.The instructions for use (ifu) included with the device provides: "precautions: in order to ensure device compatibility, choose a sheath size large enough to accommodate the maximum outer diameter of any devices that will be placed through the sheath.All interventional or diagnostic instruments used with this product should move freely through the valve and sheath to avoid damage." potential adverse events include "bleeding." sheath introduction: "insert the dilator/sheath assembly over the wire guide.Remove the wire guide and dilator, then aspirate and flush through the sheath side-arm.Insert appropriately sized device(s) as needed." based on the information provided, no product returned, and the results of our investigation, it has been concluded a cause for this event could not be established.The appropriate personnel have been notified of this event.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8273861
• Report Number: 1820334-2019-00166
• Device Sequence Number: 10804985
• Product Code: DYB
• UDI-Device Identifier: 00827002562790
• UDI-Public: (01)00827002562790(17)211126(10)9331984
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142829
• 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,Followup,Followup
• Report Date (Section B): 03/23/2020

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 Expiration Date: 11/26/2021
• Device Model Number: G56279
• Device Catalogue Number: KCFW-12.0-35-45-RB-HFANL0-HC
• Device Lot Number: 9331984
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 04/19/2019; 03/20/2020
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 04/23/2019; 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1