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

Model Number	D0610062575
Medical Device Problem Codes	Material Rupture (1546); Structural Problem (2506); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
Balloon ruptured as balloon was being removed.The balloon did not appear to have ruptured longitudinally.Unable to totally withdraw, with some of balloon remaining in fistulagram, the physician did a cut-down to remove.No patient injury and the incident was not reported.
Additional Manufacturer Narrative
Follow up report to provide information not known at the time of the original report, such as investigation type, findings, and conclusion.
Event or Problem Description
Follow up report for cc2020-066-ir; mfr report#: 3005994106-2020-00066.

• Brand Name: DYNAMIS AV
• Common Device Name: 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: 10208556
• Report Number: 3005994106-2020-00066
• Device Sequence Number: 2552440
• Product Code: LIT
• UDI-Device Identifier: 05391525783321
• UDI-Public: 05391525783321
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K113468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2020

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 Model Number: D0610062575
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown