MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS PERFORMA PERIPHERAL CATHETER

Catalog Number	7503-13/B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/07/2019
Type of Reportable Event	Serious Injury
Additional 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.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem 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
• Common Device Name: PERIPHERAL CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego, CA 92154
• MDR Report Key: 9385085
• Report Number: 3011642792-2019-00026
• Device Sequence Number: 2402632
• Product Code: DQO
• UDI-Device Identifier: 00884450004265
• UDI-Public: 00884450004265
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K943739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 7503-13/B
• Device Lot Number: I1239496
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention