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

Model Number	G56201
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device will not be returned.Three unused devices from the same lot will be returned for investigation.Occupation: non-healthcare professional.Pma/510(k) number: k171275.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an unknown procedure via access in the femoral artery, a micropuncture transitionless access set hub separated from the outer catheter upon removal of the device.Resistance was not reported during the procedure and details of the patient's anatomy are unknown.The device was used to facilitate placement of a larger wire guide.Kinking was not observed.The procedure was successfully completed with the complaint device.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
Event summary: as reported, during an unknown procedure via access in the femoral artery, a micropuncture transitionless access set hub separated from the outer catheter upon removal of the device.Resistance was not reported during the procedure and details of the patient's anatomy are unknown.The device was used to facilitate placement of a larger wire guide.Kinking was not observed.The procedure was successfully completed with the complaint device.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.A review of the complaint history, device history record, documentation, manufacturing instructions, quality control procedures, specifications, and a visual inspection of unused product were conducted during the investigation.The complaint device was not returned; however, three unused devices from the same product lot were returned by the user facility.All returned devices were undamaged, and all hubs were secure.A document-based investigation evaluation was performed.A review of the design history record revealed no related nonconformances for this lot.It should be noted that there have been no other complaints associated with this lot number.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the complaint file provides evidence to support that the device and items in the lot were manufactured to specification.Based on the information provided, investigation has concluded that a cause for the device failure could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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
• MDR Report Key: 9720113
• Report Number: 1820334-2020-00389
• Device Sequence Number: 367186
• Product Code: DYB
• UDI-Device Identifier: 00827002562011
• UDI-Public: (01)00827002562011(17)221122(10)10169748
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

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: 11/22/2022
• Device Model Number: G56201
• Device Catalogue Number: MPIS-402-NT-U-SST
• Device Lot Number: 10169748
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1