MAUDE Adverse Event Report: COOK INC POLYETHYLENE ANGIOGRAPHIC CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	P5.0-35-100-P-NS-MRV-121100
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2015
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
The complainant reported that the polyethylene angiographic catheter was opened and noted to be stretched just past the hub prior to placing the catheter in the patient.Another catheter was used to complete the procedure without incident.It was further noted that the catheter was also split.The product problem(s) did not lead to any reported patient impact.

• Brand Name: POLYETHYLENE ANGIOGRAPHIC CATHETER
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8169184
• Report Number: 1820334-2018-03797
• Device Sequence Number: 1447003
• Product Code: DQO
• UDI-Device Identifier: 00827002132603
• UDI-Public: (01)00827002132603(17)171210(10)NS5484200
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/17/2018

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: 12/10/2017
• Device Catalogue Number: P5.0-35-100-P-NS-MRV-121100
• Device Lot Number: NS5484200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1