MAUDE Adverse Event Report: CREAGH MEDICAL LTD.9 DYNAMIS HP 10MM X 40MM X 75CM; PTA CATHETER

Model Number	UHP75104
Medical Device Problem Codes	Deflation Problem (1149); Retraction Problem (1536); Device-Device Incompatibility (2919); Mechanical Jam (2983)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Difficulty deflating balloon completely and withdrawn balloon from sheath.Balloon deflation required additional 10cc and 20cc syringe use.
Event or Problem Description
Follow up report for (b)(6); mfr report #: 3005994106-2020-00001.
Additional Manufacturer Narrative
Follow up report for additional information not known at the time of original report such as investigation type, findings, and conclusion.

• Brand Name: DYNAMIS HP 10MM X 40MM X 75CM
• Common Device Name: PTA CATHETER
• Manufacturer (Section D): CREAGH MEDICAL LTD.9; ida business park; ballinasloe, galway H53 H Y09; EI H53 HY09
• Manufacturer (Section G): CREAGH MEDICAL LTD.; ida business park; ballinasloe, galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: jonathan canavan ; ida business park; ballinasloe, galway H53 H-Y09 ; EI H53 HY09
• MDR Report Key: 10008109
• Report Number: 3005994106-2020-00001
• Device Sequence Number: 2953007
• Product Code: LIT
• UDI-Device Identifier: 05391525783338
• UDI-Public: 05391525783338
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020
• 2 Devices were Involved in the Event: 1 2

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: UHP75104
• Device Catalogue Number: UHP75104
• Device Lot Number: 21903331
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 04/28/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown