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 during a electromagnetic navigation bronchoscopy, the patient developed a pneumothorax.The chest tube was in place for 14 hours.No further harm or injury to the patient was reported.Merit's kit was used in the procedure but did not cause or contribute to the pneumothorax.

Manufacturer Narrative

Device evaluation: the device has not returned for evaluation.A follow up report will be submitted once the evaluation has been completed.

• 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 ; 1600 west merit parkway; south jordan, UT 84095 ; 8012084491
• MDR Report Key: 4098144
• MDR Text Key: 20018342
• Report Number: 1628221-2014-00007
• 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?: Yes
• 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