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

Model Number	G48008
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: non-healthcare professional.Pma/510(k) number: k171275.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an unknown procedure, a micropuncture transitionless stiffened cannula access set wire sheared off and was left in the patient's tissue.Resistance was reported and the needle and wire were removed, at which time the wire separated.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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
Additional information was sent to the manufacturer on (b)(6) 2020.The intended procedure was a right heart catheterization via right internal jugular access.The access site was reportedly scarred and resistance was reported upon removal of the device.The complaint wire guide, which was intended to facilitate placement of a larger wire, was removed through a needle.The separated portion of the wire, which remains in the patient's subcutaneous tissue, may possibly be removed in the future.The patient has not experienced any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Event summary: as reported, during a right heart catheterization via right internal jugular access, a micropuncture transitionless stiffened cannula access set wire sheared off and was left in the patient's tissue.The access site was reportedly scarred and resistance was reported upon removal of the device.The complaint wire guide, which was intended to facilitate placement of a larger wire, was removed through a needle.The separated portion of the wire, which remains in the patient's subcutaneous tissue, may possibly be removed in the future.The patient has not experienced any adverse effects due to this occurrence.Investigation - evaluation: reviews of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, and quality control procedures and a visual inspection of the device were conducted during the investigation.One used cope nitinol mandril wire guide (pmg-18sp-40-cope-nt) was returned.The coil end was broken and elongated.The distal weld ball was not present.There was bio-matter present.A document-based investigation evaluation was performed.A review of the device history record shows no failure-related nonconformances.There have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.No gaps were discovered in the manufacturing instructions or quality control procedures for this device.Cook has concluded that sufficient controls are in place to detect this failure mode prior to distribution.The device is packaged with instructions for use, which state, ¿when inserting, manipulating or withdrawing a device through an introducer, always maintain introducer position¿; ¿do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt¿; and, ¿withdrawal or manipulation of the distal spring coil portion of the mandril wire guide through a needle tip may result in breakage.¿ based on the information available, investigation has concluded that a definitive cause for this event could not be determined.It is possible that patient anatomy or user technique may have played a role in this failure.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 STIFFENED CANNULA ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9595692
• Report Number: 1820334-2020-00130
• Device Sequence Number: 19626996
• Product Code: DYB
• UDI-Device Identifier: 00827002480087
• UDI-Public: (01)00827002480087(17)221111(10)10141671
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2022
• Device Model Number: G48008
• Device Catalogue Number: MPIS-501-10.0-SC-NT-U-SST
• Device Lot Number: 10141671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 01/13/2020; 06/26/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 01/20/2020; 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other