MAUDE Adverse Event Report: COOK INC PERFORMER MULLINS GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	G07816
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not used.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 by the distributor, while inspecting the performer mullins guiding sheath, a unidentified particle was noted within the primary packaging of the product.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
Event summary: as reported by the distributor, while inspecting the performer mullins guiding sheath, an unidentified particle was noted within the primary packaging of the product.This device did not make patient contact.Investigation - evaluation: reviews of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, and quality control of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.Images were provided by the distributor showing an unknown foreign material within the product packaging.A document-based investigation evaluation was also conducted.A review of the device history showed no failure-related nonconforming events.It should be noted there were no other reported lot-related complaints.No gaps were discovered in the manufacturing instructions, specifications, or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.There is no evidence that additional nonconforming product exists in-house or in the field.The product is packaged with instructions for use, which state, ¿do not use the product if there is doubt as to whether the product is sterile.¿ based on the information available, investigation has concluded that a manufacturing and quality control deficiency contributed to this incident.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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: PERFORMER MULLINS GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9383317
• Report Number: 1820334-2019-02968
• Device Sequence Number: 2403273
• Product Code: DYB
• UDI-Device Identifier: 00827002078161
• UDI-Public: (01)00827002078161(17)220621(10)9829026
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2020

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: 06/21/2022
• Device Model Number: G07816
• Device Catalogue Number: RCFW-7.0-38-63-RB-MTS
• Device Lot Number: 9829026
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 06/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1