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

Model Number	G48006
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown if the complaint device will be returned for physical investigation.Additional information has been requested.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, the wire of a micropuncture transitionless stiffened cannula access set unraveled during an undisclosed procedure.Access was gained through the femoral artery.When retracting the wire, the tip uncoiled and was retained in the artery wall.The patient will require surgery to remove the wire fragment.No adverse effects have been reported due to this occurrence.Additional patient and event information has been requested.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Description of event: as reported, the wire of a micropuncture transitionless stiffened cannula access set unraveled during an undisclosed procedure.Access was gained through the femoral artery.When retracting the wire, the tip uncoiled and was retained in the artery wall.The patient will require surgery to remove the wire fragment.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.The complainant returned one unused mpis-501-10.0-sc-sst from the same lot number to cook for investigation.No damage to the wire guide was noted.A document-based investigation evaluation was performed.One potentially relevant nonconformance was recorded; all affected devices were scrapped.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.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: ¿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.Withdrawal or manipulation of the distal spring coil portion of the mandril wire guide through a needle tip may result in breakage.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Based on the available information, cook has concluded that patient anatomy may have contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 11956770
• Report Number: 1820334-2021-01473
• Device Sequence Number: 1402870
• Product Code: DYB
• UDI-Device Identifier: 00827002480063
• UDI-Public: (01)00827002480063(17)240120(10)13704053
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K171275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/01/2021

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: 01/20/2024
• Device Model Number: G48006
• Device Catalogue Number: MPIS-501-10.0-SC-SST
• Device Lot Number: 13704053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 11/01/2021
• 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