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

Catalog Number	RCFW-18.0P-38-30-RB
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: customer name and address = address line 2: halfway house.(b)(6).E3: occupation = regulatory affairs manager.G4: pma/510(k) number = k171999.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
As reported, during an endovascular aneurysm repair, a performer introducer leaked at the hub.The device was opened and the sheath was flushed with saline.When the dilator was inserted into the sheath, it would not advance; therefore, the physician used force to push the dilator through the sheath.The sheath and dilator were then successfully introduced into the left femoral artery.When the dilator was removed from the sheath, the hemostatic sheath valve leaked.The physician then attempted to introduce another manufacturer's stent graft into the sheath; however, it would not fit in the sheath.The sheath was removed normally, and another sheath from the same lot was used to complete the procedure.The stent graft was introduced into the replacement sheath without difficulty.The anatomy was not tortuous, scarred, or calcified.The complaint sheath was in place less than five minutes.Resistance was not encountered upon insertion or removal of the sheath.The tips of the sheath and dilator were not damaged.Vessel spasms did not occur.Per the reporter, "some" blood loss occurred when the large sheath was removed; however, the patient did not require treatment for blood loss.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
H3: 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 21aug2023, the silicone disc was dislodged from the hub.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an endovascular aneurysm repair, a performer introducer leaked at the hub.The device was opened, and the sheath was flushed with saline.When the dilator was inserted into the sheath, it would not advance; therefore, the physician used force to push the dilator through the sheath.The sheath and dilator were then successfully introduced into the left femoral artery.When the dilator was removed from the sheath, the hemostatic sheath valve leaked.The physician then attempted to introduce another manufacturer's stent graft into the sheath; however, it would not fit in the sheath.The sheath was removed normally, and another sheath from the same lot was used to complete the procedure.The stent graft was introduced into the replacement sheath without difficulty.The anatomy was not tortuous, scarred, or calcified.The complaint sheath was in place less than five minutes.Resistance was not encountered upon insertion or removal of the sheath.The tips of the sheath and dilator were not damaged.Vessel spasms did not occur.Per the reporter, "some" blood loss occurred when the large sheath was removed; however, the patient did not require treatment for blood loss.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.Upon return and initial evaluation of the device on 21aug2023, the silicone disc was dislodged from the hub.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, specifications, and quality control procedures were conducted during the investigation.A visual inspection and dimensional verification of the complaint device was also conducted.The complaint device was returned to cook for investigation.The silicone disc was not present in the hub, as it had dislodged and was found within the sheath.The inner diameter of the hub and outer diameter of the dilator tubing were measured within specification.The disc slits were normal.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional complaints for this lot number.The product ifu states ¿insert the dilator completely into the introducer.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.A review of the device master record (dmr) 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 a component failure, unrelated to manufacturing or design deficiencies, contributed to this event.The user reported that force was used to insert the dilator into the sheath and a stent was also unable to be inserted into the sheath.It is likely that the silicone disc was dislodged by the dilator; however, the exact conditions experienced during the procedure cannot be duplicated in the lab.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
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 17557950
• Report Number: 1820334-2023-01099
• Device Sequence Number: 3640198
• Product Code: DYB
• UDI-Device Identifier: 00827002116726
• UDI-Public: (01)00827002116726(17)260206(10)15209218
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2023

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: 02/06/2026
• Device Catalogue Number: RCFW-18.0P-38-30-RB
• Device Lot Number: 15209218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 08/21/2023; 11/17/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/14/2023; 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC ENDURANT II AUI GRAFT.
• Patient Age: 69 YR
• Patient Sex: Male