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

Model Number	UHP7584
Medical Device Problem Codes	Retraction Problem (1536); Mechanical Jam (2983)
Health Effect - Clinical Codes	Physical Entrapment (2327); Foreign Body In Patient (2687)
Date of Event	08/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User reports they had a balloon rupture as it was being inflated and while removing the balloon got stuck in the patient.The balloon was unable to be retrieved.Some other issues include running them over the wire and them being resistant.The unit was returned to the manufacturer without any accompanying event description, subsequent inquiries by the manufacturer established details of the malfunction.
Event or Problem Description
The user reports they had a balloon rupture as it was being inflated and while removing the balloon got stuck in the patient.The balloon was unable to be retrieved.Some other issues include running them over the wire and them being resistant.
Event or Problem Description
Follow up report for (b)(6), mfr.Report #: 3005994106-2019-00010.
Additional Manufacturer Narrative
Follow up report to provided information not known at the time of original submission, such as investigation type, findings, and conclusion.

• 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, H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: shane costello ; ida business park; ballinasloe, H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 9346031
• Report Number: 3005994106-2019-00010
• Device Sequence Number: 18999667
• Product Code: LIT
• UDI-Device Identifier: 05391525783208
• UDI-Public: 05391525783208
• 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
• Report Date (Section B): 09/25/2019

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 Expiration Date: 02/21/2021
• Device Model Number: UHP7584
• Device Catalogue Number: UHP7584
• Device Lot Number: 21800423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 11/20/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown