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

Model Number	G43872
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter occupation = radiology technologist (rt).(b)(4).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 a procedure involving placement of a port, a micropuncture transitionless access set's wire separated in the patient.The separated portion of the wire was initially unable to be retrieved; however, a surgical consult was obtained and the wire was removed.Additional information has been requested, but is unavailable at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: a2, a3, a4, a5b, b3, b5, e4, f2.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 received 19feb2021 via a medwatch 3500a.During placement of a port-a-cath in interventional radiology, the left internal jugular vein was visualized under fluoroscopy with image documentation of needle entry into the left internal jugular.An attempt to advance the guidewire centrally was unsuccessful and in removing the needle and guidewire, the guidewire was fractured, and a segment was lodged in the subcutaneous tissue.Attempts at removal were unsuccessful and surgery was called for assistance.The surgeon was able to extend the incision by 1-centimeter to allow for dissection and was able to grasp the tissue in which the guidewire was embedded and remove the fragment.The radiologist was then able to complete port-a-cath placement without further incident.
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, unchanged, or unavailable.Summary of event: as reported, during a procedure involving placement of a port, a micropuncture transitionless access set's wire separated in the patient.The separated portion of the wire was initially unable to be retrieved; however, a surgical consult was obtained and the wire was removed.Additional information was received 19feb2021 via a medwatch 3500a.During placement of a port-a-cath in interventional radiology, the left internal jugular vein was visualized under fluoroscopy with image documentation of needle entry into the left internal jugular.An attempt to advance the guidewire centrally was unsuccessful and in removing the needle and guidewire, the guidewire was fractured, and a segment was lodged in the subcutaneous tissue.Attempts at removal were unsuccessful and surgery was called for assistance.The surgeon was able to extend the incision by 1-centimeter to allow for dissection and was able to grasp the tissue in which the guidewire was embedded and remove the fragment.The radiologist was then able to complete port-a-cath placement without further incident.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.Physical examination of the returned device showed the entire wire guide was not returned.Only an elongated section of the wire coil was received.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.Evidence from the complaint file, device history record, complaint history, manufacturing documents, and device failure analysis suggests that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.The product ifu instructs the user to inspect the product to ensure no damage has occurred upon removal from the package, not to withdraw or manipulate the wire guide through a needle, and not to attempt to withdraw the wire guide if resistance is felt.Based on the information provided and the results of the investigation, cook has concluded that device failure contributed to the event.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.

• 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: 11323179
• Report Number: 1820334-2021-00325
• Device Sequence Number: 17175224
• Product Code: DYB
• UDI-Device Identifier: 00827002438729
• UDI-Public: (01)00827002438729(17)231123(10)13585145
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K171275
• 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): 06/03/2021

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: 11/23/2023
• Device Model Number: G43872
• Device Catalogue Number: MPIS-505-SST
• Device Lot Number: 13585145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 02/19/2021; 05/06/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 02/24/2021; 06/03/2021
• 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: Required Intervention
• Patient Age: 41 YR
• Patient Weight: 89