MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS PERFORMA CARDIOLOGY CATHETER

Model Number	00884450002902
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined visually.The complaint is confirmed.No definitive root cause could be determined however, it is likely that excessive force was applied to the device during use.A search of the complaint database found no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found for the lot.
Additional Manufacturer Narrative
The device has returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a percutaneous transluminal peripheral vascular procedure, 5cm of the 4f catheter tip detached within the patient.

• Brand Name: PERFORMA CARDIOLOGY CATHETER
• Common Device Name: CARDIOLOGY CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva road #100; san diego CA 92154
• MDR Report Key: 9501088
• Report Number: 3011642792-2019-00028
• Device Sequence Number: 2001934
• Product Code: DQO
• UDI-Device Identifier: 00884450002902
• UDI-Public: 00884450002902
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 00884450002902
• Device Catalogue Number: 7718-A0/B
• Device Lot Number: 11311335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1