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

Catalog Number	MPIS-402-NT-U-SST
Medical Device Problem Codes	Unraveled Material (1664); Difficult to Advance (2920)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3 - occupation: assistant nurse manager.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.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
As reported, during an unknown procedure, a micropuncture transitionless access set's wire unraveled.While obtaining access through femoral artery, the wire was difficult to advance through the needle.The user removed the wire from the patient and the wire was unraveled/uncoiled.Additional information was requested.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: h3: (other): the device has been returned and preliminary evaluation has been performed; however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.Correction: h6 annex e and annex f 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.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
Additional information was received on 21nov2023 stating there were no documented issues regarding the access site and access was not obtained under ultrasound guidance.The procedure was successfully completed with a new micropuncture introducer set.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 occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an unknown procedure, a micropuncture transitionless access set's wire unraveled.While obtaining access through femoral artery, the wire was difficult to advance through the needle.The user removed the wire from the patient and the wire was unraveled/uncoiled.Additional information was received on 21nov2023 stating there were no documented issues regarding the access site and access was not obtained under ultrasound guidance.The procedure was successfully completed with a new micropuncture introducer set.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 occurrence.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, 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.Approximately 15.5-centimeters of the wire was unraveled, beginning approximately 34.8-centimeters from the distal tip.The overall length of the elongated portion was 51.7-centimeters.The distal weld ball was intact.A document-based investigation evaluation was performed.A review of the device history record found two relevant non-conformances on fourteen total devices from a sub-assembly lot; however, all affected product was scrapped, and the lot was 100% inspected.A review of complaint history found no additional complaints for the final or subassembly 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.Although two relevant non-conformances were noted on a sub-assembly lot, all non-conforming product was scrapped, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot-related complaints have been received from the field.Therefore, it was concluded that there is no evidence that additional non-conforming product exists 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 design or manufacturing, 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.
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
• 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: 18160062
• Report Number: 1820334-2023-01582
• Device Sequence Number: 17972405
• Product Code: DYB
• UDI-Device Identifier: 00827002562011
• UDI-Public: (01)00827002562011(17)260830(10)15634692
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K171275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2024

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 Expiration Date: 08/30/2026
• Device Catalogue Number: MPIS-402-NT-U-SST
• Device Lot Number: 15634692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 11/21/2023; 03/07/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 12/14/2023; 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• 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
• Patient Sex: Unknown