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

Model Number	G29983
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = non-healthcare professional (buyer).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
It was reported that the bottom of the flexor ansel guiding sheath's packaging was open and not sealed.This was noticed upon the receipt of the device while storing the product for future procedures.This device did not make patient contact.
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: it was reported that the bottom of the flexor ansel guiding sheath's packaging was open and not sealed.This was noticed upon the receipt of the device while storing the product for future procedures.This device did not make patient contact.Investigation evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, and quality control was conducted during the investigation, as well as a visual inspection of the complaint device.The complaint device was returned for investigation in the original package.The bottom of the pouch was not sealed.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.There is, however, evidence to suggest from the complaint file and manufacturing/quality control documents that the complaint device was manufactured out of specification.The product ifu states: ¿sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.¿ & ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ there were no gaps identified in the manufacturing or quality control processes.Adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints have been received from the field.Thus, there is no evidence to suggest that there are any additional nonconforming devices in the lot or in the field.Based on the information provided and the results of the investigation, cook has concluded that the cause for this event can be traced to manufacturing and quality control.Re-training has been completed for personnel responsible for the sealing and quality control of the device.Risk was assessed for this complaint event.No risk escalation activities are recommended at this time.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: 9488759
• Report Number: 1820334-2019-03138
• Device Sequence Number: 11108801
• Product Code: DYB
• UDI-Device Identifier: 00827002299832
• UDI-Public: (01)00827002299832(17)221021(10)10095125
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/29/2020

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: Health Professional
• Device Expiration Date: 10/21/2022
• Device Model Number: G29983
• Device Catalogue Number: KCFW-6.0-18/38-45-RB-ANL2-HC
• Device Lot Number: 10095125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 12/18/2019
• 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