MAUDE Adverse Event Report: CREAGH MEDICAL LTD FIRST CHOICE; PTA CATHETER

Model Number	UHP75164
Health Effect - Clinical Codes	Thrombosis (2100); Insufficient Information (4580)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports 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 8fr 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 of extra supplies.The patient did have a dvt post procedure and is being treated for a dvt.It is also reported that no product will be returning.
Event or Problem Description
Customer reports 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 8fr 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 of extra supplies.The patient did have a dvt post procedure and is being treated for a dvt.It is also reported that no product will be returning.
Additional Manufacturer Narrative
Customer reports 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 8fr 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 of extra supplies.The patient did have a dvt post procedure and is being treated for a dvt.It is also reported that no product will be returning.Investigation summary: this complaint could neither be confirmed, or the root cause determined.The device was not returned for evaluation.The customer did not provide any batch details for the implicated device, nor was the implicated device returned, therefore an investigation was not possible.This failure mode is documented in the design fmea.Conclusion: the root cause of this issue is currently unknown.
Event or Problem Description
Follow-up report to submit additional information not known at time of initial submission.

• Brand Name: FIRST CHOICE
• Common Device Name: 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, galway H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 8503381
• Report Number: 3005994106-2019-00005
• Device Sequence Number: 11264129
• Product Code: LIT
• UDI-Device Identifier: 05391525783369
• UDI-Public: 05391525783369
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K143561
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2019

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 Model Number: UHP75164
• Device Catalogue Number: UHP75164
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019; 03/18/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 12/16/2019; 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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