MAUDE Adverse Event Report: MERIT MEDICAL RICHMOND PERICARDIOCENTESIS KIT; IRRIGATION CATHETER

Catalog Number PC805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pericardial Effusion (3271)

Event Date 07/04/2018

Event Type  Injury  

Manufacturer Narrative

The device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during an emergent pericardiocentesis procedure the physician found it difficult to insert the dilator through the patient's dermis located at the solor plexus.A new drainage catheter was opened and successfully placed without incident.

Manufacturer Narrative

The suspect device was returned for evaluation.The device was examined visually and microscopically.The complaint is confirmed.The root cause could not be determined, however, rough handling during use is suspected.A review of the device history record was performed and no exception doucments were found.A review of the complaint database was performed and no similar complaints for this lot number were found.

• Brand Name: PERICARDIOCENTESIS KIT
• Type of Device: IRRIGATION CATHETER
• Manufacturer (Section D): MERIT MEDICAL RICHMOND; 12701 n kingston ave; chester VA 23836
• MDR Report Key: 7718558
• MDR Text Key: 114978421
• Report Number: 1125782-2018-00024
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/04/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: PC805
• Device Lot Number: T1072072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Initial Date Manufacturer Received: 07/04/2018
• Initial Date FDA Received: 07/25/2018
• Supplement Dates Manufacturer Received: 10/11/2018
• Supplement Dates FDA Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening