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

Model Number	G48186
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = non-healthcare professional.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
As originally reported, upon opening a flexor ansel guiding sheath for an unknown procedure, an adhesive material or coating was found on the outside of the hydrophilic-coated sheath.Information provided by the customer on 25nov2019 confirmed that the adhesive coating "appeared to only be in certain areas of the sheath".The device did not make contact with any patient.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Correction: g5, h3.The device was not returned to cook.Summary of event: as originally reported, upon opening a flexor ansel guiding sheath for an unknown procedure, an adhesive material or coating was found on the outside of the hydrophilic-coated sheath.Information provided by the customer on (b)(6) 2019 confirmed that the adhesive coating "appeared to only be in certain areas of the sheath".The device did not make contact with any patient.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), and quality control was conducted during the investigation.The complaint device was not returned; therefore, a visual inspection of the device was not possible.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The complaint file, device history record, complaint history, validations, and manufacturing documents provide 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.The product ifu states: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ a review of the manufacturer¿s instructions and quality control procedures was conducted, and no gaps were discovered.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a definitive cause for this event cannot be established.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 regarding the patient and/or event 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: 9452362
• Report Number: 1820334-2019-03087
• Device Sequence Number: 16914129
• Product Code: DYB
• UDI-Device Identifier: 00827002481862
• UDI-Public: (01)00827002481862(17)220619(10)9822759
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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: 06/19/2022
• Device Model Number: G48186
• Device Catalogue Number: KCFW-4.0-18/35-45-RB-ANL0-HC
• Device Lot Number: 9822759
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1