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

Model Number	G31138
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = non-healthcare professional- distributor.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 reported, during inspection within a distribution facility, an unidentified particle was found in the package of a flexor shuttle select guiding sheath.The device did not make contact with any patient.
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
Summary of event: as reported, during inspection within a distribution facility, an unidentified particle was found in the package of a flexor shuttle select guiding sheath.The device did not contact any patient.Investigation evaluation: a review of the complaint history, device history record, and quality control was conducted during the investigation, as well as a visual inspection of photos provided by the customer.The complaint device was not returned; however, photos were provided.An unidentified particle was noted inside the sealed packaging.A document-based investigation evaluation was performed.No related non-conformances were found.There have been no additional complaints associated with this lot number.There is no evidence of additional nonconforming devices from the complaint lot in house or in the field.The product ifu instructs the user to inspect the product to ensure no damage has occurred 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 of the event is related to manufacturing.However, as there are no other complaints on the lot or additional 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 SHUTTLE SELECT GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9606793
• Report Number: 1820334-2020-00153
• Device Sequence Number: 2721059
• Product Code: DYB
• UDI-Device Identifier: 00827002311381
• UDI-Public: (01)00827002311381(17)220917(10)10016689
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153430
• 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): 04/29/2020

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: No Information
• Device Expiration Date: 09/17/2022
• Device Model Number: G31138
• Device Catalogue Number: KSAW-6.0-38-90-RB-SHTL-FLEX-HC
• Device Lot Number: 10016689
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1