MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. SURECROSS SUPPORT CATHETER.

Model Number	00884450187753
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2020
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 peripheral vascular intervention procedure the marker band on the support catheter detached within the patient.The physician had acquired retrograde arterial vascular access and during support catheter manipulations over the wire within the patients left lower limb when crossing the lesion, the radiopaque marker band detached but remained on the guidewire.The marker band was successfully retrieved with the support of an additional guide wire.The patient tolerated the procedure well.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.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.Corrective actions are in process.

• Brand Name: SURECROSS SUPPORT CATHETER.
• Common Device Name: SUPPORT CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston, tx
• MDR Report Key: 10189958
• Report Number: 3010665433-2020-00018
• Device Sequence Number: 3574255
• Product Code: DQY
• UDI-Device Identifier: 00884450187753
• UDI-Public: 00884450187753
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K123311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

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: 09/30/2021
• Device Model Number: 00884450187753
• Device Catalogue Number: SC35150/B
• Device Lot Number: E1414394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER; GUIDE WIRE
• Patient Age: 88 YR
• Patient Weight: 68