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

Model Number UHP7584

Device Problems Retraction Problem (1536); Material Rupture (1546); Mechanical Jam (2983)

Patient Problems Physical Entrapment (2327); Foreign Body In Patient (2687)

Event Date 08/09/2019

Event Type  malfunction  

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 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 Description

Follow up report for (b)(6), mfr.Report #: 3005994106-2019-00010.

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
• Type of Device: 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
• MDR Text Key: 191919561
• Report Number: 3005994106-2019-00010
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 05391525783208
• UDI-Public: 05391525783208
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/16/2019
• 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
• Patient Outcome(s): Other