MAUDE Adverse Event Report: CREAGH MEDICAL LTD PASSEO-35 HP; PTA CATHETER

Model Number	PASSEO-35 HP 8/40/75
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was receiving a fistulogram with intervention.A balloon was introduced in the fistula and burst during inflation.On system removal, it was noted that the marker band at the balloon tip had broken off into the tissue.Tip was left in the patient.
Event or Problem Description
Patient was receiving a fistulagram with intervention.A balloon was introduced in the fistula and burst during inflation.On system removal, it was noted that the marker band at the balloon tip had broken off into the tissue.Tip was left in the patient.
Additional Manufacturer Narrative
Top assembly batch history record was reviewed.All processed to the correct validated parameters by trained personnel.All units were 100% visually inspected and leak tested to rated burst pressure.The correct work instructions were utilized at the correct revisions and all operators that worked on the batch in question were fully trained on their respective work steps.The components used in the manufacture of this batch are consistent with those used on all passeo-35 hp product.There were no capa's, ncr's or deviations associated with the batch in question.No unusual anomalies were noted following the batch review.All rejected units reconciled correctly with the bhr quantity.The unit has not been returned for further investigation.
Additional Manufacturer Narrative
Follow-up report to submit additional information not known at time of initial submission.
Event or Problem Description
Follow-up report to submit additional information not known at time of initial submission.

• Brand Name: PASSEO-35 HP
• Common Device Name: PTA CATHETER
• Manufacturer (Section D): CREAGH MEDICAL LTD; creagh medical ltd; ida business park; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL LTD; ida business park; ballinasloe; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: eoin mcevoy ; ida business park; ballinasloe; ballinasloe, co. galway H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 7860670
• Report Number: 3005994106-2018-00001
• Device Sequence Number: 19125448
• Product Code: LIT
• UDI-Device Identifier: 05391525781563
• UDI-Public: 05391525781563
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/12/2018
• Device Model Number: PASSEO-35 HP 8/40/75
• Device Catalogue Number: 399092
• Device Lot Number: 21501303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 08/10/2018; 08/10/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 10/02/2018; 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2015
• 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
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White