MAUDE Adverse Event Report: COOK INC DILATOR; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	G02366
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: unknown.Pma/510k: preamendment.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
During a port insertion procedure it was reported that a cook dilator separated upon removal.No resistance was encountered upon the removal.The physician was able to remove the portion of the separated dilator that was "extravascular" over the wire that was in place.No additional procedures were required.No adverse effects to the patient were reported.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Correction: upon further review, it was determined this event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury or reportable product malfunction as there is no indication of the malfunction leading to an ae.Further discussion with regulatory reporting, clinical specialists, and medical advisor determined that the "physician was able to grasp the dilator and remove it over the wire that was in place, as there was a portion of it extravascular" does not constitute medical intervention to preclude permanent impairment or death for this event.Therefore, this event is no longer considered a serious injury per 21 cfr part 803.3.Additionally, a review of reporting software revealed that no similar events where the ncd dilator separated resulted in heightened patient risk.As there are no recorded incidences of serious injury due to the reported failure mode and it is not likely that serious injury would result if the event were to recur the event is not reportable per 21cfr part 803.50.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.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.
Event or Problem Description
This event no longer meets the qualifications for a reportable event.See h10.

• Brand Name: DILATOR
• Common Device Name: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 12207080
• Report Number: 1820334-2021-01845
• Device Sequence Number: 4370614
• Product Code: DRE
• UDI-Device Identifier: 00827002023666
• UDI-Public: (01)00827002023666(17)240413(10)13827656
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: 04/13/2024
• Device Model Number: G02366
• Device Catalogue Number: NCD4.0-35-20
• Device Lot Number: 13827656
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male