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

Device Problems Material Rupture (1546); Structural Problem (2506); Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)

Event Date 05/18/2020

Event Type  Injury  

Event Description

Balloon that burst inside a patient today and the patient was transported to the emergency department with the balloon still in the patient.Rep is collecting more information.Customer feedback stated: that upon asking for further information it became evident that a stent had been implanted, and came into contact with the metal stent and this contact ruptured the balloon.

Manufacturer Narrative

Follow up report to provide information not known at the time of original report, such as, investigation type, findings, and conclusion.

Event Description

Follow up report for (b)(4); mfr report#: 3005994106-2020-00055.

• Type of Device: PTA CATHETER
• Manufacturer (Section G): CREAGH MEDICAL LTD.; ida business park; ballinasloe, co. galway galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: jonathan canavan ; ida business park; ballinasloe, co. galway galway H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 10143544
• MDR Text Key: 194884631
• Report Number: 3005994106-2020-00055
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K113468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention