MAUDE Adverse Event Report: COOK INC LOCK PERICARDIOCENTESIS CATHETER SET; GBX CATHETER, IRRIGATION

Catalog Number	C-PCS-830-LOCK
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2015
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 pericardial drain was used and the guide wire unraveled (the mesh disassembled) during withdrawal.There were no reported adverse effects to the patient as a result of the product problem.

• Brand Name: LOCK PERICARDIOCENTESIS CATHETER SET
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7377065
• Report Number: 1820334-2018-00892
• Device Sequence Number: 13726110
• Product Code: GBX
• UDI-Device Identifier: 00827002024335
• UDI-Public: (01)00827002024335(17)161001(10)4599044
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/28/2018

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 Catalogue Number: C-PCS-830-LOCK
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1