MAUDE Adverse Event Report: COOK INC WHITE VESSEL SIZING CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	N5.0-35-70-P-10S-PIG-WSC
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2016
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 the physician placed the white vessel sizing catheter in the patient and connected the high pressure tubing to the hub, but the hub cracked when fluid was injected.It was then reported that this happened again with a second device with the same lot number.It is unknown how the procedure was completed, but there were no injuries or additional procedures reported.

• Brand Name: WHITE VESSEL SIZING CATHETER
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8175406
• Report Number: 1820334-2018-03845
• Device Sequence Number: 2639918
• Product Code: DQO
• UDI-Device Identifier: 00827002051898
• UDI-Public: (01)00827002051898(17)180816(10)NS6083144
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2018

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 Expiration Date: 08/16/2018
• Device Catalogue Number: N5.0-35-70-P-10S-PIG-WSC
• Device Lot Number: NS6083144
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1