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

Model Number	G47942
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer name and address= address line 2: (b)(6).Postal code: (b)(6).Phone: (b)(6).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 preparation of the device, prior to use for an unknown procedure, a micropuncture transitionless access set's coaxial catheter was "broken".A photo provided by the customer shows what appears to be a separated sheath/outer cannula tip sitting on the dilator/inner cannula.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, unchanged, or unavailable.Summary of event: as reported, during preparation of the device, prior to use for an unknown procedure, a micropuncture transitionless access set's coaxial catheter was "broken".A photo provided by the customer shows what appears to be a separated sheath/outer cannula tip sitting on the dilator/inner cannula.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), and quality control procedures were conducted during the investigation.A visual inspection of a provided photo was also conducted.Although the complaint device was not returned to cook, a photo of the complaint device was provided by the customer.The photo appears to show separation of the outer cannula/sheath tip; however, the outer cannula/sheath and the tip remain on the inner cannula/dilator.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The introducer component lots associated with the final lot recorded two relevant non-conformances; however, all non-conforming product was scrapped.A complaint history search of the associated component lots found no additional complaints from the field.Investigation of all lots manufactured and checked by the same personnel, during the same week as the complaint device, found no additional complaints from the field.There has been no increase in the occurrence rate for this failure mode.Therefore, cook has concluded that this is an isolated event.The information provided upon review of the dmr, dhr, ifu, and investigation of the photo provided by the customer suggests that there is evidence the device was manufactured out of specification.However, there is no evidence of additional nonconforming devices in house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the available information and results of the investigation, cook has concluded that a manufacturing and quality control deficiency contributed to this event; however, there is no evidence of additional nonconforming devices in house or in the field.The responsible personnel were notified.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: 17318399
• Report Number: 1820334-2023-00895
• Device Sequence Number: 17698784
• Product Code: DYB
• UDI-Device Identifier: 00827002479425
• UDI-Public: (01)00827002479425(17)260329(10)NS15298694
• 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): 10/18/2023

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: 03/29/2026
• Device Model Number: G47942
• Device Catalogue Number: MPIS-401-NT-SST
• Device Lot Number: NS15298694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• 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