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

Model Number	G47940
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.H3: device evaluation anticipated, but not yet begun.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 a fistulagram of the left arm, a micropuncture transitionless access set¿s sheath separated.The micropuncture set and wire were inserted into the access site, which was reportedly normal.Resistance was not encountered during insertion or removal of the device; however, upon withdrawal of the device, the sheath tore, leaving a fragment inside the patient.The physician was able to retrieve the fragment via a cut-down.Per the reporter, a small additional incision was made, the wire was pulled, and the torn sheath fragment was successfully retrieved with forceps.The procedure was completed successfully.A section of the device did not remain inside the patient¿s body.The patient did not experience any adverse effects due to this event.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during a fistulogram of the left arm, a micropuncture traditionless access set¿s sheath separated.The micropuncture set and wire were inserted into the access site, which was reportedly normal.Resistance was not encountered during insertion or removal of the device; however, upon withdrawal of the device, the sheath tore, leaving a fragment inside the patient.The physician was able to retrieve the fragment via a cut-down.Per the reporter, a small additional incision was made, the wire was pulled, and the torn sheath fragment was successfully retrieved with forceps.The procedure was completed successfully.A section of the device did not remain inside the patient¿s body.The patient did not experience any adverse effects due to this event.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The outer cannula was separated, at approximately the middle of the shaft.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional complaints for this lot number, or on any other lot containing the same raw material lot as the complaint device.The product ifu cautions ¿when inserting, manipulating or withdrawing a device through an introducer, always maintain introducer position¿ and ¿do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt¿.Wire or catheter embolism is listed as a potential adverse event.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A supplier investigation was requested.The supplier found no issues related to the manufacture of the supplied component.The information provided upon review of the dmr, dhr, ifu, customer-provided photos, and investigation of the returned device 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.Based on the information provided and the results of the investigation, cook has concluded that a component failure contributed to this event.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.

• 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: 22105005
• Report Number: 1820334-2025-00608
• Device Sequence Number: 7023357
• Product Code: DYB
• UDI-Device Identifier: 00827002479401
• UDI-Public: (01)00827002479401(17)271204(10)16365872
• Combination Product (Y/N): N
• PMA/510(K) Number: K240589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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 Model Number: G47940
• Device Catalogue Number: MPIS-401-SST
• Device Lot Number: 16365872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COOK TSFB-35-145, LOT 16276878
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male