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

Model Number	G48002
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, while attempting to obtain access for an angioplasty procedure, a micropuncture transitionless stiffened cannula access set¿s sheath separated in the patient upon insertion of the device.The sheath was not advanced or removed through a previously placed vascular closure device.The sheath reportedly separated where the sheath and hub meet, and no sheath material remained in the hub.It is unknown if the procedure was completed.The separated fragment was removed.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this event.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: a2, a3, a4, a5, a6, b5, e4.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
Additional information was received 02jun2025.After the hub separated, part of the sheath remained outside the body; therefore, the physician was able to remove the separated portion intact, without complications or patient harm.Fluoroscopy was used to confirm that the entire sheath had been removed.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, while attempting to obtain access for an angioplasty procedure, a micropuncture transitionless stiffened cannula access set¿s sheath separated in the patient upon insertion of the device.The sheath was not advanced or removed through a previously placed vascular closure device.The sheath reportedly separated where the sheath and hub meet, and no sheath material remained in the hub.It is unknown if the procedure was completed.The separated fragment was removed.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this event.Additional information was received 02jun2025.After the hub separated, part of the sheath remained outside the body; therefore, the physician was able to remove the separated portion intact, without complications or patient harm.Fluoroscopy was used to confirm that the entire sheath had been removed.Corrected information: h6 (annex a).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 sheath was detached from the hub; however, sheath material remained in the hub.The sheath was elongated at the point of separation and scratched on the outside.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the final or sub-assembly lots.A review of complaint history found no additional complaints for the final or sub-assembly lots.The product ifu states ¿do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.¿ a review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, 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, unrelated to manufacturing or design deficiencies, 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 STIFFENED CANNULA 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: 22096030
• Report Number: 1820334-2025-00605
• Device Sequence Number: 12777463
• Product Code: DYB
• UDI-Device Identifier: 00827002480025
• UDI-Public: (01)00827002480025(17)280128(10)16439716
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G48002
• Device Catalogue Number: MPIS-401-10.0-SC-SST
• Device Lot Number: 16439716
• 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: 06/02/2025; 11/12/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/06/2025; 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2025
• 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
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White