MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS PERFORMA CARDIOLOGY CATHETER

Catalog Number	5100381ULT2/B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is 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 a percutaneous transluminal coronary angiogram procedure, the catheter tip detached within the patient.The physician had acquired retrograde femoral artery access and was trying to negotiate the patient's common iliac bifurcation when the catheter tip detached.The physician was able to successfully remove the detached catheter tip along with the guidewire by hand through the access sheath.The patient tolerated the procedure well.No patient injury to report.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was 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.

• Brand Name: PERFORMA CARDIOLOGY CATHETER
• Common Device Name: CARDIOLOGY CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego, CA 92154
• MDR Report Key: 9333519
• Report Number: 3011642792-2019-00024
• Device Sequence Number: 2030635
• Product Code: DQO
• UDI-Device Identifier: 00884450043257
• UDI-Public: 00884450043257
• 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): 10/21/2019

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: 10/31/2020
• Device Catalogue Number: 5100381ULT2/B
• Device Lot Number: I1226444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 11/17/2019
• 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