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

Model Number	G47946
Medical Device Problem Codes	Break (1069); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/17/2023
Type of Reportable Event	Serious Injury
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
As reported, during placement of a power port, a micropuncture transitionless pediatric access set's wire unraveled and separated.The wire was advanced through the micropuncture needle; however, the wire was difficult to advance.The user then attempted to remove the wire through the needle, but the wire would not move.The user pulled on the wire again, and the wire began to unravel.The wire was removed; however, the tip separated in the patient.Fluoroscopy was used to locate the wire fragment, and an incision was made for tissue exploration.The wire fragment was located and removed from the patient.Intraoperative fluoroscopy confirmed removal of the wire.Additional information has been requested.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Corrected information: d9, h3: the complaint device was not returned to cook for investigation.Summary of event: as reported, during placement of a power port, a micropuncture transitionless pediatric access set's wire unraveled and separated.The wire was advanced through the micropuncture needle; however, the wire was difficult to advance.The user then attempted to remove the wire through the needle, but the wire would not move.The user pulled on the wire again, and the wire began to unravel.The wire was removed; however, the tip separated in the patient.Fluoroscopy was used to locate the wire fragment, and an incision was made for tissue exploration.The wire fragment was located and removed from the patient.Intraoperative fluoroscopy confirmed removal of the wire.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), specifications, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu states ¿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 ifu suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that failure to follow instructions contributed to this event.The user attempted to forcibly remove the wire through the needle, despite meeting resistance.The ifu instructs the user not to withdraw the wire through the needle, as breakage may result, and instructs to remove the wire and needle as a unit if the wire must be withdrawn while the needle is inserted.The risk analysis for this failure mode was reviewed and no additional escalation was 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.
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 PEDIATRIC 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: 16863392
• Report Number: 1820334-2023-00540
• Device Sequence Number: 20188785
• Product Code: DYB
• UDI-Device Identifier: 00827002479463
• UDI-Public: (01)00827002479463(17)260104(10)15147412
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 09/26/2023

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: 01/04/2026
• Device Model Number: G47946
• Device Catalogue Number: MPIS-401-PED-NT-SST
• Device Lot Number: 15147412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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
• Patient Sex: Unknown