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

Catalog Number	RCFW-14.0-38-45-RB
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.B3: event date= "about two weeks ago".G4: pma/510(k) number = k171999.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
As reported, during a procedure intended to retrieve another manufacturer's inferior vena cava filter, a performer introducer "crumpled" in two places while trying to retrieve the filter, using another manufacturer's snare.Access was obtained in the internal jugular vein.It is unknown if the anatomy was tortuous, calcified, or scarred.Resistance was encountered upon removal of the filter, which was unable to be pulled through the sheath.The sheath buckled.Upon return and initial evaluation of the complaint device, the sheath was buckled/kinked/damaged in three places, and the tip was damaged.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
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 03aug2023.A "lot" of force was used during attempted removal of the filter, which was stuck in the performer introducer.The filter was successfully retrieved.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Corrected information: h1: upon further review, this event is not reportable under fda 21 cfr part 803.Although cook has previously reported similar events, a detailed search of previous complaints using a validated report found no deaths or serious injuries associated with this device and failure mode since 01jan2020.An mdr guidance for manufacturers issued in 1997 stated that once a malfunction has caused or contributed to a death or serious injury, a presumption that the malfunction is likely to cause or contribute to a death or serious injury has been established.This presumption will continue until either the malfunction has caused or contributed to no further deaths or serious injuries for two years, or the manufacturer can show through valid data that the likelihood of another death or serious injury as a result of the malfunction is remote.Therefore, based on current information, this event no longer meets the set criteria for a reportable event.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.

• 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: 17405049
• Report Number: 1820334-2023-00967
• Device Sequence Number: 12243079
• Product Code: DYB
• UDI-Device Identifier: 00827002284388
• UDI-Public: (01)00827002284388(17)250613(10)14790762
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2023

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: 06/13/2025
• Device Catalogue Number: RCFW-14.0-38-45-RB
• Device Lot Number: 14790762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 08/03/2023; 11/16/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 08/11/2023; 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2022
• 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: ARGON HALO SINGLE LOOP SNARE 6F 15X120 LOT11451533.; ARGON IVC FILTER.
• Patient Sex: Unknown