MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS PERFORMA PERIPHERAL CATHETER

Catalog Number 7503-13/B

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem Death (1802)

Event Date 11/07/2019

Event Type  Injury  

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during and percutaneous transluminal coronary angioplasty [ptca] procedure, the (b)(6)-year-old patient coded and expired.The physician had acquired retrograde arterial access to successfully deploy a coronary stent.During the procedure, the catheter tip detached within the renal artery branch.The physician attempted unsuccessfully to remove the detached catheter tip from the patient.A renal ultrasound was ordered and completed successfully.The patient became hypotensive, the physician administered noradrenalin to increase the patients' blood pressure / volume.The ekg demonstrated st-elevation and ventricular tachycardia arrhythmia.The physician urgently performed an additional angiogram attempting to identify the culprit occlusion.Acute stent thrombosis was evident.The patient coded and acls protocol was directed for approximately 35min.Sudden cardiac arrest (sca) was confirmed.

• 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: 9385085
• MDR Text Key: 185333554
• Report Number: 3011642792-2019-00026
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450004265
• UDI-Public: 00884450004265
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 7503-13/B
• Device Lot Number: I1239496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2017
• 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