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

Catalog Number	RCFW-14.0-38-30-RB
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, prior to use during a transcatheter aortic valve implantation procedure, the tip of a performer introducer was found to be split/cracked.The device was not used.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
E1: customer name and address: address line 2: (b)(6).Postal code: (b)(6).Phone: (b)(6).Email: (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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.B1, h1: upon return and investigation of the device on (b)(6) 2023, the sheath tip was folded/creased, but was not split as reported by the customer.Per a search of risk documentation and previous complaint data, there is no evidence to suggest that this device failure would be likely to cause or contribute to a death or a serious injury if the failure were to recur.Furthermore, there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury was alleged, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.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: 17715186
• Report Number: 1820334-2023-01213
• Device Sequence Number: 16681587
• Product Code: DYB
• UDI-Device Identifier: 00827002089570
• UDI-Public: (01)00827002089570(17)260609(10)15483559
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 06/09/2026
• Device Catalogue Number: RCFW-14.0-38-30-RB
• Device Lot Number: 15483559
• 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: 08/21/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2023
• 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
• Patient Sex: Unknown