MAUDE Adverse Event Report: CREAGH MEDICAL LTD DYNAMIS; 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	07/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports during procedure under normal usage conditions the balloon popped.No patient harm was reported.
Additional Manufacturer Narrative
The customer reports during procedure under normal usage conditions the balloon popped.No patient harm was reported.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 reports during procedure under normal usage conditions the balloon popped.No patient harm was reported.
Event or Problem Description
Follow up report for (b)(4); mfr report #: 3005994106-2019-00008.
Additional Manufacturer Narrative
Follow up report for information not known at time of original report such as investigation type, findings, and conclusion.

• Brand Name: DYNAMIS
• 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, H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: shane costello ; ida business park; ballinasloe, H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 8803253
• Report Number: 3005994106-2019-00008
• Device Sequence Number: 13534958
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,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: 21801034
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/18/2019
• 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