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

Model Number	UHP75124
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Event or Problem 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 burst device.All three devices had the same lot number and expiration date (lot3 22001203, exp- 6/2/23).
Event or Problem Description
Follow up report for (b)(6); mfr report #: 3005994106-2020-00079.
Additional Manufacturer Narrative
Follow up report provide information not known at the time of the original report, such as, investigation type, findings, and conclusion.

• 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: 10409451
• Report Number: 3005994106-2020-00079
• Device Sequence Number: 2751021
• Product Code: LIT
• UDI-Device Identifier: 05391525783345
• UDI-Public: 05391525783345
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K143561
• 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): 08/11/2020

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: 06/02/2023
• Device Model Number: UHP75124
• Device Lot Number: 22001203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/14/2020
• 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
• Patient Sex: Unknown