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

Model Number	G09210
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma/510(k) number: pre-amendment.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, prior to use, the hub of a performer mullins guiding sheath dilator was found to be separated from the device.This observation was made prior to opening the sterile package.The device did not make patient contact.
Additional Manufacturer Narrative
Device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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
Upon return and initial evaluation of the device on (b)(6) 2019, three dark foreign matter fibers were noted by the distal seal of the inner pouch.One was within the seal and two were free-floating.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary.As reported, prior to use, the hub of a performer mullins guiding sheath dilator was found to be separated from the device.This observation was made prior to opening the sterile package.The device did not make patient contact.Investigation - evaluation.Reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures and a visual inspection and dimensional verification of the device were conducted during the investigation.One unopened rcfw-14.0-38-75-rb-mts was returned for investigation.The hub of the 14 fr dilator is separated within the sealed inner pouch.Three dark foreign matter fibers were noted by the cook seal (distal end).One fiber was found in the seal, and the other two were free-floating in the inner pouch with the 14 fr dilator.The connector cap inner diameter was found to be out of specification for the final product.Additionally, a document-based investigation evaluation was performed.A review of the device history showed no failure-related nonconforming events.It should be noted there were no other reported lot-related complaints.Thus, there is no evidence to suggest that there are any additional nonconforming devices in the lot or in the field.The product is packaged with instructions for use, which state, ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information available, investigation has concluded that both the dilator hub separation and the observed foreign matter can be attributed to possible manufacturing and quality control deficiencies.Retraining has been initiated for personnel involved in the manufacturing and quality inspection of this device.A capa investigation has been previously opened for dilator hub separation and is currently ongoing.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.
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: PERFORMER MULLINS GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9187039
• Report Number: 1820334-2019-02589
• Device Sequence Number: 16759315
• Product Code: DYB
• UDI-Device Identifier: 00827002092105
• UDI-Public: (01)00827002092105(17)220129(10)NS9485485
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: Health Professional
• Device Expiration Date: 01/29/2022
• Device Model Number: G09210
• Device Catalogue Number: RCFW-14.0-38-75-RB-MTS
• Device Lot Number: NS9485485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 11/01/2019; 06/09/2020
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 11/08/2019; 06/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1