MAUDE Adverse Event Report: CREAGH MEDICAL LTD. ADVANCE SERENITY 18 HYDROPHILLIC OTW PTA BALLOON CATHETER; PTA CATHETER

Model Number SER18-150-30-100

Device Problems Material Rupture (1546); Material Separation (1562)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2020

Event Type  malfunction  

Event Description

Balloon was used in the distal sfa.Upon the second inflation the balloon burst at 12 atm.No portion detached.

Event Description

Follow-up report to submit additional information not known at time of initial submission.

• Brand Name: ADVANCE SERENITY 18 HYDROPHILLIC OTW PTA BALLOON CATHETER
• Type of Device: PTA CATHETER
• Manufacturer (Section D): CREAGH MEDICAL LTD.; ida business park; creagh road; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL LTD.; ida business park; creagh road; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: michelle donnellan ; ida business park; creagh road; ballinasloe, co. galway H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 10449007
• MDR Text Key: 209815538
• Report Number: 3005994106-2020-00090
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 05391525784175
• UDI-Public: 05391525784175
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K180007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2023
• Device Model Number: SER18-150-30-100
• Device Lot Number: 22000955
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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