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

Model Number UHP7584

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

The customer has reported noticing a hole in the balloon. No further information has been provided at the time of the initial 30-day report.

Event Description

The customer has reported noticing a hole in the balloon.

• Brand Name: DYNAMIS HP
• Type of Device: DYNAMIS HP PTA BALLOON DILATATION 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: 8896531
• MDR Text Key: 191919445
• Report Number: 3005994106-2019-00009
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UHP7584
• Device Lot Number: 21801323
• Was Device Available for Evaluation?: No Answer Provided

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial