MAUDE Adverse Event Report: COOK INC DESILETS-HOFFMAN INTRODUCER SET; KOE DILATOR, URETHRAL

Model Number	G18089
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
It was reported that during a demonstration of the desilets-hoffman introducer set, fine strands of an unknown material began protruding from the van-andel end of the 8fr dilator.There was no patient involvement, so there were no injuries or additional procedures reported.

• Brand Name: DESILETS-HOFFMAN INTRODUCER SET
• Common Device Name: KOE DILATOR, URETHRAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7422352
• Report Number: 1820334-2018-01119
• Device Sequence Number: 1769299
• Product Code: KOE
• UDI-Device Identifier: 00827002180895
• UDI-Public: (01)00827002180895(17)190502(10)6938106
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

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 Model Number: G18089
• Device Catalogue Number: DHIS-080030-RB-DIL88
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1