MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS PERFORMA PERIPHERAL CATHETER

Catalog Number 7523-13/B

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

Patient Problem Atrial Perforation (2511)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a selective coronary angiogram [sca], the catheter tip dissected the ostium of the right coronary artery [rca] during diagnostic catheter manipulations over a guide wire.The physician successfully covered and treated the dissection by deploying a drug eluting sent [des] within the patient's rca.No additional patient consequences to report.

• Brand Name: PERFORMA PERIPHERAL CATHETER
• Type of Device: PERIPHERAL CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego, CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego, CA 92154
• Manufacturer Contact: david lockridge ; 1600 merit parkway; south jordan, UT 84095 ; 8012084551
• MDR Report Key: 9292655
• MDR Text Key: 166984194
• Report Number: 3011642792-2019-00022
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450004265
• UDI-Public: 00884450004265
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K943739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 7523-13/B
• Device Lot Number: I1543420
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention