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

Model Number	G09908
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an unknown procedure, a flexor introducer sheath leaked from the valve.The device had been inserted with an antegrade approach to the common femoral artery.Shortly after sheath insertion, the device began leaking or "pulsating".The anatomy was not calcified, tortuous, or scarred.The sheath and dilator were removed as a unit, without resistance, after being in place for 45 minutes.Minimal blood loss was reported.No adverse effects to the patient have been reported.
Additional Manufacturer Narrative
Event summary: as reported, during an unknown procedure, a flexor introducer sheath leaked from the valve.The device had been inserted with an antegrade approach to the common femoral artery.Shortly after sheath insertion, the device began leaking or "pulsating".The anatomy was not calcified, tortuous, or scarred.The sheath and dilator were removed as a unit, without resistance, after being in place for 45 minutes.Minimal blood loss was reported.No adverse effects to the patient have been reported.Investigation - evaluation: a document-based investigation was performed including a review of complaint history, device history record, manufacturing instructions, quality control data, and the instructions for use (ifu).The complaint device was not returned; therefore, no physical examinations could be performed.A review of the device history record found 1 relevant non-conformance; all affected devices were scrapped, and there are 100% inspection to capture this non-conformance.A review of complaint history records shows no other complaints associated with the complaint device lot.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.No gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: ¿instructions for use¿: ¿using the side-arm of the valve, flush the sheath by filling the sheath assembly completely with heparinized saline.¿ ¿how supplied¿: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the available information, cook has concluded a component failure contributed to this failure mode.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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 new patient or event information since the last report was submitted.

• 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: 12142496
• Report Number: 1820334-2021-01727
• Device Sequence Number: 4154821
• Product Code: DYB
• UDI-Device Identifier: 00827002099081
• UDI-Public: (01)00827002099081(17)240330(10)13856359
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

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: 03/30/2024
• Device Model Number: G09908
• Device Catalogue Number: KCFW-6.0-35-45-RB
• Device Lot Number: 13856359
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1