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

Catalog Number	MPIS-401-NT-U-SST
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As originally reported, during a percutaneous transluminal angioplasty procedure, a micropuncture transitionless access set's dilator kinked upon insertion of the device.Antegrade access was obtained in the femoral artery to target a chronic total occlusion/lesion in the superficial femoral artery.As the user attempted to insert the introducer/dilator pair into the patient, the dilator reportedly kinked, and the user removed the device.Another device of the same type (unknown lot) was used to complete the procedure.The device package was not damaged.Upon return and initial evaluation of the device, the sheath/outer cannula was split at the tip.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.H3: 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.
Additional Manufacturer Narrative
Corrected information: h6- annex a.Summary of event: as originally reported, during a percutaneous transluminal angioplasty procedure, a micropuncture transitionless access set's dilator kinked upon insertion of the device.Antegrade access was obtained in the femoral artery to target a chronic total occlusion/lesion in the superficial femoral artery.As the user attempted to insert the introducer/dilator pair into the patient, the dilator reportedly kinked, and the user removed the device.Another device of the same type (unknown lot) was used to complete the procedure.The device package was not damaged.Upon return and initial evaluation of the device, the sheath/outer cannula was split at the tip.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 (dhr), instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.Two used sheaths/outer catheters and one used dilator/inner catheter were returned to cook for investigation.Two kinks were noted on the dilator.The tip of one sheath was pushed inward and split.The second used sheath was undamaged and is presumed to be the replacement device that was used to complete the procedure.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the final lot.One relevant non-conformance was noted on two devices from a component lot; however, all affected product was scrapped.A review of complaint history found three additional relevant complaints for the final lot number and two additional relevant complaints associated with the sub-assembly lot.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 one relevant non-conformance was noted on a component lot and additional complaints were noted on the final and sub-assembly lots, all non-conforming product was scrapped, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, and there is objective evidence that the dhr was fully executed.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 manufacturing or design deficiencies, contributed to this event.The exact conditions experienced during the event cannot be duplicated.Details of the anatomy are unknown, and it is unknown if resistance was encountered during use.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: 19053729
• Report Number: 1820334-2024-00478
• Device Sequence Number: 20588088
• Product Code: DYB
• UDI-Device Identifier: 00827002479449
• UDI-Public: (01)00827002479449(17)260703(10)15517494
• Combination Product (Y/N): N
• PMA/510(K) Number: K171275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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: 07/03/2026
• Device Catalogue Number: MPIS-401-NT-U-SST
• Device Lot Number: 15517494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• 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: Male