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

Model Number	G47950
Medical Device Problem Codes	Break (1069); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the wire included in a micropuncture transitionless access set unraveled and separated.Ultrasound guidance was used to access the left internal jugular vein with the micropuncture transitionless access set.The microwire went through the needle easily, but as the sheath was inserted, the wire unraveled.The surgeon attempted to extract the wire using fluoroscopic guidance; however, the tip of the unraveled wire was noted to be stuck in the wall of the jugular vein (confirmed with ultrasound).The surgeon pulled out "what would come out" and left the remaining portion of the wire in the vein.The retained fragment was clearly identified using fluoroscopy.The surgeon elected to leave the wire in place after considering the risks and benefits of retrieving the device through an open incision.Additional information has been requested.
Additional Manufacturer Narrative
This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
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
Summary of event: as reported, the wire included in a micropuncture transitionless access set unraveled and separated.Ultrasound guidance was used to access the left internal jugular vein with the micropuncture transitionless access set.The microwire went through the needle easily, but as the sheath was inserted, the wire unraveled.The surgeon attempted to extract the wire using fluoroscopic guidance; however, the tip of the unraveled wire was noted to be stuck in the wall of the jugular vein (confirmed with ultrasound).The surgeon pulled out "what would come out" and left the remaining portion of the wire in the vein.The retained fragment was clearly identified using fluoroscopy.The surgeon elected to leave the wire in place after considering the risks and benefits of retrieving the device through an open incision.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu) and quality control procedures were conducted during the investigation.The user did not return the complaint device to cook for investigation.Cook completed a review of the device history record (dhr).The dhr for the reported lot recorded no relevant non-conformances.A related component associated with the complaint lot found 3 relevant non-conformances; all non-conforming product was scrapped, and there are 100% inspections to capture this non-conformance.There are no other lot related complaints that have been received from the field.At this time, cook concluded that no non-conforming product from this lot exists in house or in the field.A document review was completed as a response to this event.A device master record (dmr) review was performed, and the device quality control procedures associated with the complaint were identified.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: 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.¿ ¿withdrawal or manipulation of the distal spring coil portion of the mandril wire guide through a needle tip may result in breakage.¿ cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to 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: 13513914
• Report Number: 1820334-2022-00201
• Device Sequence Number: 19929721
• Product Code: DYB
• UDI-Device Identifier: 00827002479500
• UDI-Public: (01)00827002479500(17)241107(10)14336024
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K171275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/07/2024
• Device Model Number: G47950
• Device Catalogue Number: MPIS-405-SST
• Device Lot Number: 14336024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown