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

Model Number UHP7584

Device Problem Material Puncture/Hole (1504)

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

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.

Manufacturer Narrative

The customer has reported noticing a hole in the balloon.No further information was provided at the time of the initial 30-day report.This complaint could neither be confirmed, or the root cause determined.The device was not returned for evaluation.A review of the batch history records and process controls has been carried out.The units were processed to the correct validated parameters.All units from this batch were subjected to a 100% final inspection process, including 100% wet leak testing.All units were inspected under a 10x vision system and all observed defective units were removed.All manufacturing operations were completed by fully trained operators.The current inspection & testing controls in place are deemed effective.All associated batch records have been reviewed and no anomalies or unusual data readings have been noted during this investigation.This failure mode is documented in the design fmea.Conclusion: the root cause of this issue is currently unknown.

Event Description

The customer has reported noticing a hole in the balloon.

Event Description

Follow up report for (b)(6); mfr.Report #: 3005994106-2019-00009.

Manufacturer Narrative

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

• Brand Name: DYNAMIS HP
• Type of Device: PTA CATHETEER
• 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
• UDI-Device Identifier: 05391525783284
• UDI-Public: 05391525783284
• 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,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UHP7584
• Device Lot Number: 21801323
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 07/22/2019; 07/22/2019
• Supplement Dates FDA Received: 12/16/2019; 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1