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

Model Number	G12424
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer name and address: (b)(6).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 transarterial chemoembolization (tace) procedure, a performer introducer leaked at the hub after the device was placed in the patient.Another sheath was used to successfully complete the procedure.Additional information has been requested, but is unavailable at this time.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
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
Additional information was received 07jan2021.Access was obtained in the femoral artery and the device was advanced to the liver.The patient did not require any intervention due to the event.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Description of event: as reported, during a transarterial chemoembolization (tace) procedure, a performer introducer leaked at the hub after the device was placed in the patient.Access was obtained in the femoral artery and the device was advanced to the liver.Another sheath was used to successfully complete the procedure.Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, and quality control data.The complainant returned one used rcfn-5.0-18-mpis-nt sheath to cook for investigation.Physical examination of the returned device showed biomatter present on the returned device.The sheath was flushed, leakage was found at the check-flo cap / sheath material section.The check-flo cap was removed to find a hole in the flare.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.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: intended use ¿introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic interventional devices.¿ precautions: ¿the maximum diameter of the instrument or catheter to be introduced should be determined to ensure its passage through the introducer.All instruments or catheters used with this product should move freely through the valve and sheath.Damage to the valve / introducer may result when the fit is tight.¿ how supplied ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded component failure contributed to this incident.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.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11094532
• Report Number: 1820334-2020-02387
• Device Sequence Number: 3609278
• Product Code: DYB
• UDI-Device Identifier: 00827002124240
• UDI-Public: (01)00827002124240(17)231029(10)13425541
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 04/23/2021

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: 10/29/2023
• Device Model Number: G12424
• Device Catalogue Number: RCFN-5.0-18-MPIS-NT
• Device Lot Number: 13425541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 01/07/2021; 04/01/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 01/11/2021; 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1