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

Model Number	UHP75124
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported a balloon burst during the procedure at 17 atmospheres.No harm to patient.
Additional Manufacturer Narrative
Follow up report to add information not known at the time of original report such as investigation type, findings and conclusion.
Event or Problem Description
Follow up report for (b)(6), mfr report: 3005994106-2019-00007.

• Brand Name: DYNAMIS HP
• Common Device Name: PTA CATHETER
• Manufacturer (Section D): CREAGH MEDICAL LTD; ida business park; ballinasloe, H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL LTD; ida business park; ballinasloe, galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: shane costello ; ida business park; ballinasloe, H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 8803241
• Report Number: 3005994106-2019-00007
• Device Sequence Number: 326682
• Product Code: LIT
• UDI-Device Identifier: 05391525783345
• UDI-Public: 05391525783345
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2019

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 Model Number: UHP75124
• Device Catalogue Number: UHP75124
• Device Lot Number: 21801330
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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