MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PERFORMA DIAGNOSTIC CATHETER

Model Number	00884450011256
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up report will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that the during a vascular procedure, the 4f catheter tip detached within the patient.The physician acquired retrograde vascular access and during catheter manipulations the catheter tip detached.The physician used a vascular snare device to retrieve the tip from the patient with no additional consequences to report.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined visually and microscopically.The complaint is confirmed.The root cause was unable to 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.

• Brand Name: PERFORMA DIAGNOSTIC CATHETER
• Common Device Name: DIAGNOSTIC CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• MDR Report Key: 9594349
• Report Number: 3011642792-2020-00002
• Device Sequence Number: 3244956
• Product Code: DQO
• UDI-Device Identifier: 00884450011256
• UDI-Public: 00884450011256
• 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): 12/17/2019

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: 06/30/2021
• Device Model Number: 00884450011256
• Device Catalogue Number: 7749-A0/B
• Device Lot Number: I1350486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 03/19/2020
• 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