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

Model Number	G29995
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 was found inside the package of a flexor ansel guiding sheath.The device did not make patient contact.
Event or Problem Description
Additional information was received 01jul2020.The package was unopened when the hair was found.The device did not make contact with the patient or any other products used during the procedure.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, unavailable, or unchanged.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, a hair was found inside the unopened package of a flexor ansel guiding sheath.The device did not make patient contact.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: reviews of the complaint history, device history record, documentation, instructions for use (ifu), and quality control were conducted during the investigation.A visual inspection of the unused complaint device was also conducted.The complaint device was returned for investigation.A hair was found in the sealed package.No other issues were noted.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.Given this information, there is no evidence to suggest that additional product with this issue exists in-house or in the field.The product ifu instructs the user to inspect the product upon removal from the package and not to 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 the most likely cause for this complaint is related to manufacturing.However, as there are no other complaints on the lot or non-conformances, the incident was most likely isolated to a single unit.The quality controls in place were also reviewed, it was concluded that there are sufficient inspection steps in place to prevent this from occurring in the future.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.

• 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: 10201339
• Report Number: 1820334-2020-01207
• Device Sequence Number: 11024248
• Product Code: DYB
• UDI-Device Identifier: 00827002299955
• UDI-Public: (01)00827002299955(17)230317(10)13059449
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/26/2020

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: 03/17/2023
• Device Model Number: G29995
• Device Catalogue Number: KSAW-5.0-18/38-55-RB-ANL1-HC
• Device Lot Number: 13059449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 07/01/2020; 10/15/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 07/08/2020; 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1