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

Model Number	G47940
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per the medwatch 3500a, it is unknown if the device will be returned.Occupation: program project coordinator pma/510(k) number: k171275.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
As reported via fda medwatch 3500a, during an unspecified procedure, a wire included in the micropuncture transitionless access set became stuck and remains in the patient.The wire was used to access the right internal jugular vein (rij); however, the device was not advanced into the lumen of the vessel.The wire reportedly became stuck near the rij and was left in the body.The physician did not have the ability to safely remove the device.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information - attachments: a second medwatch report was provided, noting the same information received on the original.Both reports are attached for reference.Initial report.As reported via fda medwatch 3500a, during an unspecified procedure, a wire included in the micropuncture transitionless access set became stuck and remains in the patient.The wire was used to access the right internal jugular vein (rij); however, the device was not advanced into the lumen of the vessel.The wire reportedly became stuck near the rij and was left in the body.The physician did not have the ability to safely remove the device.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.Investigation evaluation.Reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawings, and quality control procedures were conducted, and no gaps were discovered.The evidence of these reviews indicates the product was made to specifications.Based on the information provided and no product returned, investigation has concluded that a root cause for this event could not be established.This case was evaluated for risk and no additional risk mitigation activity is necessary, as severity and occurrence rates are low.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: MICROPUNCTURE TRANSITIONLESS ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9451126
• Report Number: 1820334-2019-03081
• Device Sequence Number: 2158922
• Product Code: DYB
• UDI-Device Identifier: 00827002479401
• UDI-Public: (01)00827002479401(17)220523(10)9763188
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2020

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: 05/23/2022
• Device Model Number: G47940
• Device Catalogue Number: MPIS-401-SST
• Device Lot Number: 9763188
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 YR