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

Model Number	UHP7584
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has reported noticing a hole in the balloon.No further information has been provided at the time of the initial 30-day report.
Event or Problem Description
The customer has reported noticing a hole in the balloon.
Additional Manufacturer Narrative
The customer has reported noticing a hole in the balloon.No further information was provided at the time of the initial 30-day report.This complaint could neither be confirmed, or the root cause determined.The device was not returned for evaluation.A review of the batch history records and process controls has been carried out.The units were processed to the correct validated parameters.All units from this batch were subjected to a 100% final inspection process, including 100% wet leak testing.All units were inspected under a 10x vision system and all observed defective units were removed.All manufacturing operations were completed by fully trained operators.The current inspection & testing controls in place are deemed effective.All associated batch records have been reviewed and no anomalies or unusual data readings have been noted during this investigation.This failure mode is documented in the design fmea.Conclusion: the root cause of this issue is currently unknown.
Event or Problem Description
The customer has reported noticing a hole in the balloon.
Event or Problem Description
Follow up report for (b)(6); mfr.Report #: 3005994106-2019-00009.
Additional Manufacturer Narrative
Follow up report to provide information not known at the time of the original submission, such as investigation type, findings, and conclusion.

• Brand Name: DYNAMIS HP
• Common Device Name: PTA CATHETEER
• 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, H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: shane costello ; ida business park; ballinasloe, H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 8896531
• Report Number: 3005994106-2019-00009
• Device Sequence Number: 11262805
• Product Code: LIT
• UDI-Device Identifier: 05391525783284
• UDI-Public: 05391525783284
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K102645
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2019

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: UHP7584
• Device Lot Number: 21801323
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 07/22/2019; 07/22/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 12/16/2019; 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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