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

Model Number	G30000
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
As reported, a hair-like foreign matter was observed inside the sterile package of a flexor ansel guiding sheath.This was observed by a distributor.The device did not make patient contact.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: section c, d10.Corrected information: d5, h6- device code.Summary of event: as reported, a hair-like foreign matter was observed inside the sterile package of a flexor ansel guiding sheath.This was observed by a distributor.The device did not make patient contact.Investigation evaluation: reviews of the complaint history, device history record, instructions for use, and quality control procedures of the device were conducted during the investigation, as well as a visual inspection of the complaint device and an inspection of unused product.The sealed complaint device was returned to cook for investigation.Inspection found a dark fiber inside the sealed packaging.Cook confirmed that the device was manufactured out of specification.A document-based investigation evaluation was performed.No related non-conformances were found in association to the reported complaint device lot, and there have been no other reported complaints for this lot number.Given this information, there is no evidence to suggest that additional non-conforming product exists in house or in the field.Cook reviewed the controls in place for the complaint device.The packaging is 100% inspected for this failure prior to distribution.Additionally, a review of the design history file (dhf) showed that this device is both safe and effective for its intended use.The instructions for use packaged with the device states "do not use the product if there is doubt as to whether the product is sterile." based on the information provided and the results of the investigation, cook has concluded that a definitive root cause for this event is related to a quality control deficiency.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 has been received since the previous medwatch report was sent.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10014028
• Report Number: 1820334-2020-00887
• Device Sequence Number: 19658995
• Product Code: DYB
• UDI-Device Identifier: 00827002300002
• UDI-Public: (01)00827002300002(17)230129(10)10296615
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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: 01/29/2023
• Device Model Number: G30000
• Device Catalogue Number: KSAW-7.0-18/38-55-RB-ANL2-HC
• Device Lot Number: 10296615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Initial Date Received by Manufacturer: 04/25/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1