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

Model Number	G43871
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Date of event = "sometime" the week of (b)(6) 2023.Occupation = interventional radiology lead.Device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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 an unspecified procedure, a micropuncture transitionless access set's wire guide unraveled upon insertion of the device.After needle access was obtained, the user inserted the wire guide through the needle.The needle was removed, and as the user attempted to insert the introducer and dilator over the wire, it was noted that the wire had started to unravel, preventing the dilator from advancing over the wire.The physician was able to complete the procedure without complication.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Summary of event: as reported, during an unspecified procedure, a micropuncture transitionless access set's wire guide unraveled upon insertion of the device.After needle access was obtained, the user inserted the wire guide through the needle.The needle was removed, and as the user attempted to insert the introducer and dilator over the wire, it was noted that the wire had started to unravel, preventing the dilator from advancing over the wire.The physician was able to complete the procedure without complication.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), quality control procedures along with a visual examination were conducted during the investigation.The complainant returned the used wire to cook for investigation.The wire began to unravel/stretch and elongate at the solder joint 35cm from the proximal end.The weld tip was intact.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other related complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the device history record was fully executed, and no other related complaints from the lot that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.The product ifu provided the following information: precautions: do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.Withdrawal or manipulation of the distal spring coil portion of the mandril wire guide through a needle tip may result in breakage.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Evidence provided by the complaint facility, device failure analysis, device history record, complaint history, and manufacturing documents suggests that the device was manufactured to specification.Based on the provided evidence and the completed investigation, cook has determined that this complaint originated from a component failure, but a definitive cause could not be determined.The risk analysis for this failure mode was reviewed and no additional escalation is 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: 16613854
• Report Number: 1820334-2023-00311
• Device Sequence Number: 14666335
• Product Code: DYB
• UDI-Device Identifier: 00827002438712
• UDI-Public: (01)00827002438712(17)251228(10)15139446
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K171275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: 12/28/2025
• Device Model Number: G43871
• Device Catalogue Number: MPIS-501-NT-U-SST
• Device Lot Number: 15139446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2022
• 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