MAUDE Adverse Event Report: CREAGH MEDICAL LTD. TELEMARK MICROCATHETER

Model Number	SURMC135
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device detachment, the tip detached from the catheter.The tip of the catheter fractured off while trying to advance in a difficult lesion.

• Brand Name: TELEMARK MICROCATHETER
• Common Device Name: MICROCATHETER
• Manufacturer (Section D): CREAGH MEDICAL LTD.; ida business park; balinasloe, co. galway, galway H53 K 8P4; EI H53 K8P4
• MDR Report Key: 12051035
• Report Number: 3005994106-2021-00012
• Device Sequence Number: 14597713
• Product Code: DQY
• UDI-Device Identifier: 05391525782942
• UDI-Public: 05391525782942
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K173560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2021

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: 10/06/2022
• Device Model Number: SURMC135
• Device Lot Number: 21903621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR