MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PERFORMA ANGIOGRAPHIC CATHETERS; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number SDMDK1000

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

Patient Problem Pneumothorax (2012)

Event Date 08/07/2014

Event Type  Injury  

Event Description

The user reported that after a endobronchial ultrasound, the patient developed a pneumothorax.The patient had a uresil thoracic vent device placed to resolve the pneumothorax.The patient was discharged the next day.No further harm or injury to the patient was reported.Merit's kit was used in the procedure that did not cause or contribute to the pneumothorax.

Manufacturer Narrative

Device evaluation: no device is expected to be returned for evaluation.Since the lot number was not provided, the device history record and complaint database could not be reviewed.Because the unit was not returned, no evaluation could be performed.If the device is returned in the future, this investigation will be reported and an additional follow up submitted.

• Brand Name: PERFORMA ANGIOGRAPHIC CATHETERS
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; south jordan UT
• Manufacturer Contact: jerry mcphie ; 1111 south velasco; angleton, TX 84095 ; 8012084491
• MDR Report Key: 4098123
• MDR Text Key: 21312920
• Report Number: 1628221-2014-00006
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: SDMDK1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: AK1100101-01 SUPERTRAX 21 GA ASPERATING NEEDLE; 180 OLYMPUS KIT-SDK3000; AK100100-01 SUPERTRAX CYTOLOGY BRUSHES