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

Model Number	G08955
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: ir inventory manager.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 a transjugular intrahepatic portosystemic shunt procedure, another manufacturer's stent became stuck in a kinked performer introducer.The sheath was reportedly placed via the internal jugular vein into the inferior vena cava and the dilator was removed.An unknown wire guide was inside the sheath and the user attempted to insert another manufacturer's stent when the sheath kinked at the hub and mid-shaft.The stent reportedly became stuck in the sheath.A section of the device did not remain inside the patient¿s body.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
As reported, during a transjugular intrahepatic portosystemic shunt procedure, another manufacturer's stent became stuck in a kinked performer introducer.The sheath was reportedly placed via the internal jugular vein into the inferior vena cava and the dilator was removed.An unknown wire guide was inside the sheath and the user attempted to insert another manufacturer's stent when the sheath kinked at the hub and mid-shaft.The stent reportedly became stuck in the sheath.Investigation ¿ evaluation.A document based investigation was performed including a review of complaint history, device history record, drawings, the instructions for use, interview personnel, and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was made out of specification.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu) instructs the user to inspect the product to ensure that all devises used should move freely through the valve and sheath and that no damage has occurred upon removal from the package.A review of relevant manufacturing documents was conducted.It was concluded that the device in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Based on the provided evidence and the completed investigation, cook has determined that a definitive conclusion could not be determined.Possible reasons for the failure include the patient's anatomy, incompatible devices, and/or user handling.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No new patient or event information to report.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9873729
• Report Number: 1820334-2020-00673
• Device Sequence Number: 13593557
• Product Code: DYB
• UDI-Device Identifier: 00827002089556
• UDI-Public: (01)00827002089556(17)221209(10)NS10170689
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 08/12/2020

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: 12/09/2022
• Device Model Number: G08955
• Device Catalogue Number: RCFW-10.0-38-45-RB
• Device Lot Number: NS10170689
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GORE VIATOR PTB8106275