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

Model Number G28433

Device Problems Material Puncture/Hole (1504); Material Perforation (2205)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Pma/510(k) # - 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.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.

Event Description

As reported, during an endovascular aneurysm repair (evar), a performer introducer's sheath was perforated.The dilator and another manufacturer's wire were in the sheath when the dilator exited the sheath through a hole.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.Additional information has been requested.

Event Description

Additional information was received 27apr2023.The wire guide came out of a hole in the sheath, so the wire was pulled back from the hole and the sheath was exchanged for a new one.There were no adverse effects to the patient.The device was discarded.Additionally, photos provided by the customer show a hole/tear in the sheath shaft material.

Manufacturer Narrative

D9, h3 = the device was discarded and will not be returned to cook.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 Description

Additional information was received 04may2023.The sheath was used for access during a procedure involving endovascular repair of a ruptured aneurysm.The dilator came out of the sheath through a hole.The device was removed and replaced with another sheath to complete the procedure.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: a2, b5 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 Description

Additional information was received on 27jun2023.Femoral access was obtained for a contralateral approach during the standard endovascular repair case.The access site was not scarred, and the anatomy was not tortuous or calcified.Resistance was not encountered upon insertion or removal of the sheath or upon insertion or removal of other devices through the sheath.

Manufacturer Narrative

Summary of event: as reported, during an endovascular aneurysm repair (evar), a performer introducer's sheath was perforated.The dilator and another manufacturer's wire were in the sheath when the dilator exited the sheath through a hole.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.Additional information was received 27apr2023.The wire guide came out of a hole in the sheath, so the wire was pulled back from the hole and the sheath was exchanged for a new one.There were no adverse effects to the patient.The device was discarded.Additionally, photos provided by the customer show a hole/tear in the sheath shaft material.Additional information was received 04may2023.The sheath was used for access during a procedure involving endovascular repair of a ruptured aneurysm.The dilator came out of the sheath through a hole.The device was removed and replaced with another sheath to complete the procedure.Additional information was received 27jun2023.Femoral access was obtained for a contralateral approach during the standard endovascular repair case.The access site was not scarred, and the anatomy was not tortuous or calcified.Resistance was not encountered upon insertion or removal of the sheath or upon insertion or removal of other devices through the sheath.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.The device was not returned to cook for investigation, however, photos were provided, upon examination of the photos a hole was noted where the wire guide exited the sheath.The sheath damage is consistent with something exiting the sheath from the inside.A review of complaint history records shows no other related complaints associated with the complaint device lot.A review of the device history record found no non-conformances related to the reported failure mode.At this time, cook has concluded that no non-conforming product from this lot exists in house or in the field.The product ifu provided the following information: precautions: ¿when inserting, manipulating or withdrawing a device through an introducer always maintain introducer position.¿ ¿do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.¿ cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, and investigation of the complaint photos provided, suggests that there is evidence the device was manufactured to specification.Based on the available information and results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.The risk analysis for this failure mode was reviewed and no additional escalation is 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.

• Brand Name: PERFORMER INTRODUCER
• Type of Device: 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: 16701580
• MDR Text Key: 312956667
• Report Number: 1820334-2023-00382
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002284333
• UDI-Public: (01)00827002284333(17)231202(10)13497226
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2023
• Device Model Number: G28433
• Device Catalogue Number: RCFW-12.0-38-45-RB
• Device Lot Number: 13497226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LUNDERQUIST GUIDEWIRE
• Patient Age: 79 YR