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

Model Number	G11672
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 procedure involving placement of an endovascular fenestrated graft for an abdominal aortic aneurysm, a performer introducer leaked blood from the hub during and after insertion of the device.Access was obtained in the common femoral artery and resistance was encountered during insertion of the device.The iliac arteries were reportedly small and calcified.An unknown 5-french pigtail catheter and a cook sheath were placed through the complaint device, which was in place for two-to-three hours.The sheath and dilator were withdrawn as a unit "only in the beginning".The hub of the performer was used to pull the device from the patient.One unit of blood was transfused as a result of blood loss.The patient was reportedly stable.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Summary of event: as reported, during a procedure involving placement of an endovascular fenestrated graft for an abdominal aortic aneurysm, a performer introducer leaked blood from the hub during and after insertion of the device.Access was obtained in the common femoral artery and resistance was encountered during insertion of the device.The iliac arteries were reportedly small and calcified.An unknown 5-french pigtail catheter and a cook sheath were placed through the complaint device, which was in place for two-to-three hours.The sheath and dilator were withdrawn as a unit "only in the beginning".The hub of the performer was used to pull the device from the patient.One unit of blood was transfused as a result of blood loss.The patient was reportedly stable.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection and functional test of the complaint device was also conducted.A used 18.0 french rcfw sheath and dilator were returned.Extensive biological matter was present.The sheath lumen was occluded to test for leakage and leakage was noted from the silicone disc.The check flo body was disassembled, and the silicone disc was removed.The top of the disc was torn, with two full-thickness punctures on either side of the disc slits.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.Based on the device master record, device history record, device failure analysis, and design history file, there is no indication the device was manufactured out of specification.There is no evidence of nonconforming material in-house or in the field.The product ifu does not provide information regarding puncturing the check-flo valve with a needle to introduce additional devices through the sheath.However, it does state "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." cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that the cause of this complaint is use error.The returned device showed puncture marks on the silicone disc, indicating that a needle was used to create additional access through the hemostatic valve to allow for additional devices.Inserting several devices through the hemostatic valve at one time likely caused the reported blood loss, as the valve is designed to accept a singular device at a given time.The risk analysis for this failure mode was reviewed and no additional escalation was required.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.
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 INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10855260
• Report Number: 1820334-2020-02132
• Device Sequence Number: 4134876
• Product Code: DYB
• UDI-Device Identifier: 00827002116726
• UDI-Public: (01)00827002116726(17)230924(10)13387608
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2023
• Device Model Number: G11672
• Device Catalogue Number: RCFW-18.0P-38-30-RB
• Device Lot Number: 13387608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2020
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 02/19/2021
• 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: COOK Z-FEN, COOK HIGH-FLEX ANSEL SHEATH.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR