MAUDE Adverse Event Report: CREAGH MEDICAL LTD. DYNAMIS AV; 0.035" WIREGUIDED PTA CATHETER

Model Number UHP75124

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2020

Event Type  malfunction  

Event Description

Pta case in which the physician used three 12x4 first choice balloons all of which experienced issues.One burst, one leaked, and one came apart where it connects to the syringe.This report focuses on the leak device.All three devices had the same lot number and expiration date (lot3 22001203, exp- 6/2/23).

• Brand Name: DYNAMIS AV
• Type of Device: 0.035" WIREGUIDED PTA CATHETER
• Manufacturer (Section D): CREAGH MEDICAL LTD.; ida business park; creagh road; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL LTD.; ida business park; creagh road; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: jonathan canavan ; ida business park; creagh road; ballinasloe, co. galway H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 10409465
• MDR Text Key: 209815838
• Report Number: 3005994106-2020-00086
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 05391525783345
• UDI-Public: 05391525783345
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K143561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2023
• Device Model Number: UHP75124
• Device Lot Number: 22001203
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/28/2020
• Date Manufacturer Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1