MAUDE Adverse Event Report: CREAGH MEDICAL LTD DIRECT ACCESS; PTA CATHETER

Model Number	UHP75104
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Account reports after the proper balloon inflation and deflation technique was performed, when trying to remove the balloon from the sheath, it could not return through the 8 fr sheath.It inserted into the sheath with no difficulty, but it would not pull back through the 8fr sheath after the balloon had been inflated.The sheath had to be removed from the patient and a new 8fr sheath inserted because the balloon would not exit through the sheath.The patient had no complications, but this did cause unneeded procedure complications, increased procedure time and the use extra supplies.Investigation summary: 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 or Problem Description
Customer reported to staff in the field that after the proper balloon inflation and deflation technique was performed, when trying to remove the balloon from the sheath, it could not return through the 8 fr sheath.It inserted into the sheath with no difficulty, but it would not pull back through the 8fr sheath after the balloon had been inflated.The sheath had to be removed from the patient and a new 8fr sheath inserted because the balloon would not exit through the sheath.The patient had no complications, but this did cause unneeded procedure complications, increased procedure time and the use extra supplies.
Event or Problem Description
Follow-up report to submit additional information not known at time of initial submission.

• Brand Name: DIRECT ACCESS
• Common Device Name: PTA CATHETER
• Manufacturer (Section D): CREAGH MEDICAL LTD; ida business park; ballinasloe, galway H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL LTD; ida business park; ballinasloe, galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: shane costello ; ida business park; ballinasloe, galway H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 8365693
• Report Number: 3005994106-2019-00003
• Device Sequence Number: 1990426
• Product Code: LIT
• UDI-Device Identifier: 05391525783338
• UDI-Public: 05391525783338
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K102645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2021
• Device Model Number: UHP75104
• Device Catalogue Number: UHP75104
• Device Lot Number: 21800137
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown