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

Model Number	G47944
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Chest Pain (1776); Neck Pain (2433); Foreign Body In Patient (2687)
Date of Event	11/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint device was discarded at the time of the event; however, it is unknown if the device fragment that was removed from the patient will be returned.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 an electrophysiology ablation procedure, a wire included in a micropuncture transitionless access set separated.The anatomy was reportedly normal.Per the reporter, nothing unusual occurred when the device was inserted into the internal jugular artery; however, tension was encountered, and the wire was pulled out through the entry needle and replaced with a new wire.The user did not realize that part of the wire separated at that time.The patient experienced right upper chest and neck pain and was directed to the emergency room several days later by the physician.A ct scan noted an extra-luminal linear metallic object, having the appearance of a fractured wire, within the soft tissues of the base of the neck, extending into the right mediastinal region.A procedure to extract the foreign body was scheduled and performed on (b)(6) 2022 at a different hospital.
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, during an electrophysiology ablation procedure, a wire included in a micropuncture transitionless access set separated.The anatomy was reportedly normal.Per the reporter, nothing unusual occurred when the device was inserted into the internal jugular artery; however, tension was encountered, and the wire was pulled out through the entry needle and replaced with a new wire.The user did not realize that part of the wire separated at that time.The patient experienced right upper chest and neck pain and was directed to the emergency room several days later by the physician.A ct scan noted an extra-luminal linear metallic object, having the appearance of a fractured wire, within the soft tissues of the base of the neck, extending into the right mediastinal region.A procedure to extract the foreign body was scheduled and performed on (b)(6) 2022 at a different hospital.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.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other related complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.The instructions for use (ifu) states that the intended use of the device is for placement of wire guides up to 0.038-inch diameter in the peripheral vascular system when a small 21-gauge needle stick is desired.The ifu also states: ¿do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt¿; and ¿withdrawal or manipulation of the distal spring coil portion of the mandril wire guide through a needle tip may result in breakage¿.Wire or catheter embolism is listed as a potential adverse event.The ifu instructs the user: ¿do not withdraw the wire guide through the introducer needle; breakage may result.If the wire guide tip must be withdrawn while the needle is inserted, remove both the needle and the wire as a unit.¿ the information provided upon review of the dmr, dhr, and the ifu suggests that there is evidence the device was manufactured to specification.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the available information and results of the investigation, cook has concluded that unintended user error contributed to this incident.It was noted the user manipulated/pulled back the wire guide within the needle.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.
Event or Problem Description
Additional information was on 21nov2024.The original ablation procedure was intended to treat supraventricular tachycardia (svt).The patient presented to the emergency department on (b)(6) 2022 for persistent sharp pain in the right upper chest/neck.A chest x-ray was followed by a ct scan, which revealed a three-inch wire fragment in the chest.On (b)(6) 2022, the patient underwent surgery to remove the wire; however, the surgery was unsuccessful.The patient was referred to a cardiothoracic department at another facility the same day for a second surgery, during which the wire was successfully removed.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5.Corrected information: d4.The additional information was received from abbott (device manufacturer) on 21nov2024.This information does not change the investigation and the conclusion is unchanged.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: 15896058
• Report Number: 1820334-2022-01798
• Device Sequence Number: 17445351
• Product Code: DYB
• UDI-Device Identifier: 00827002479449
• UDI-Public: (01)00827002479449(17)251018(10)15025746
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K171275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2024

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: 10/18/2025
• Device Model Number: G47944
• Device Catalogue Number: MPIS-401-NT-U-SST
• Device Lot Number: 15025746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 03/10/2023; 11/21/2024
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 04/04/2023; 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 87 KG