MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS ACCESS SET; DYB INTRODUCER, CATHETER

Model Number	G47944
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a procedure described as a paracentesis, the tip of a micropuncture transitionless access set's sheath split and "turned up like a bellows" after insertion into the femoral artery.Resistance was encountered upon insertion of the sheath into the patient over the micropuncture wire.The access site was not scarred, and the sheath was not advanced through a previously placed vascular closure device.There was no damage noted to the device prior to use.Upon removal of the sheath from the patient, the tip was found to be split.Another device of the same type, from the same lot, was used to complete the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
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
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, unchanged, or unavailable.Summary of event: as reported, during a procedure described as a paracentesis, the tip of a micropuncture transition less access set's sheath split and "turned up like a bellows" after insertion into the femoral artery.Resistance was encountered upon insertion of the sheath into the patient over the micropuncture wire.The access site was not scarred, and the sheath was not advanced through a previously placed vascular closure device.There was no damage noted to the device prior to use.Upon removal of the sheath from the patient, the tip was found to be split.Another device of the same type, from the same lot, was used to complete the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Corrected information: h6 (annex g) 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.The complaint device was not returned to cook for investigation.Cook reviewed the device history record (dhr).The dhr for the device lot found no relevant non-conformances.A component lot records one relevant nonconformance, however, the devices were scrapped, and the lot is inspected 100%.A database search for complaints reported on the complaint lot reveals no additional complaints at this time.Therefore, cook determined that no nonconforming product exists in house or in the field.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: precautions do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.How supplied upon removal from package, inspect the product to ensure no damage has occurred.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 complaint file, dmr, dhr, and ifu provides evidence that the device was manufactured to specification.Based on the available information and results of the investigation, cook concluded that a component failure unrelated to the design or manufacturing of the complaint device caused this incident.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.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: MICROPUNCTURE TRANSITIONLESS ACCESS SET
• 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: 16494315
• Report Number: 1820334-2023-00230
• Device Sequence Number: 6239939
• Product Code: DYB
• UDI-Device Identifier: 00827002479449
• UDI-Public: (01)00827002479449(17)251102(10)15050550
• Combination Product (Y/N): N
• PMA/510(K) Number: K171275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2023

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: 11/02/2025
• Device Model Number: G47944
• Device Catalogue Number: MPIS-401-NT-U-SST
• Device Lot Number: 15050550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• 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
• Patient Sex: Unknown