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

Model Number	UHP7588
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Actual occurence date is unknown but estimated, customer stated it occured sometime from the week of (b)(6) 2018.
Event or Problem Description
During procedure balloon popped when they took it out there was a pin hole present.There was no patient injury from the event.

• Brand Name: DYNAMIS
• Common Device Name: PTA CATHETER
• Manufacturer (Section D): CREAGH MEDICAL LTD; ida business park; ballinasloe, galway H53 K 8P4; EI H53 K8P4
• MDR Report Key: 8059099
• Report Number: 3005994106-2018-00003
• Device Sequence Number: 11240755
• Product Code: LIT
• UDI-Device Identifier: 08570590020259
• UDI-Public: 08570590020259
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K113468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: UHP7588
• Device Lot Number: 21700160
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other