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

Model Number	PASSEO-35 HP 10/40/75
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the investigation carried out, the complaint has been confirmed.It was found that the unit in question had a pinhole present.The cause of this pinhole is unknown as all balloon catheters manufactured within creagh medical are 100% inspected and leak test to detect this particular defect type.Units are inflated and brought their specified rated burst pressure in order to confirm that units can withstand this pressure and that no defects arise during this inflation process.This unit was manufactured according to the correct validated process.All of the batch documentation and sub assembly documentation was reviewed and no issues were noted.The material and components used in this device were determined to be consistent with all materials used in the manufacture of all passeo-35 hp products.Review of the manufacturing records for this lot revealed no issues.Product is 100% visually inspected for defects.All operators that worked on the batch question were fully trained on their respective work steps.No unusual anomalies were noted in the fallout from this batch.Based on this analysis and the recreation of this type of failure within the test laboratory indicates a device use issue rather than an issue with device itself.In that units are inflated in water a pinhole such as the one seen in this unit would easily be detected and noted by the visual inspectors.The complaint is confirmed as a pin hole as this was evident on returned unit but it is thought that use error contributed to event.
Event or Problem Description
The passeo-35 hp 10/40/75 product leaks during inflation time.
Additional Manufacturer Narrative
Based on the investigation carried out, the complaint has been confirmed.It was found that the unit in question had a pinhole present.The cause of this pinhole is unknown as all balloon catheters manufactured within creagh medical are 100% inspected and leak test to detect this particular defect type.Units are inflated and brought their specified rated burst pressure in order to confirm that units can withstand this pressure and that no defects arise during this inflation process.This unit was manufactured according to the correct validated process.All of the batch documentation and sub assembly documentation was reviewed and no issues were noted.The material and components used in this device were determined to be consistent with all materials used in the manufacture of all passeo-35 hp products.Review of the manufacturing records for this lot revealed no issues.Product is 100% visually inspected for defects.All operators that worked on the batch question were fully trained on their respective work steps.No unusual anomalies were noted in the fallout from this batch.Based on this analysis and the recreation of this type of failure within the test laboratory indicates a device use issue rather than an issue with device itself.In that units are inflated in water a pinhole such as the one seen in this unit would easily be detected and noted by the visual inspectors.The complaint is confirmed as a pin hole as this was evident on returned unit but it is thought that use error contributed to event.
Event or Problem Description
The passeo-35 hp 10/40/75 product leaks during inflation time.

• Brand Name: PASSEO-35 HP
• Common Device Name: BALLOON DILATATION CATHETER
• Manufacturer (Section D): CREAGH MEDICAL LTD; ida business park; ballinasloe; n/a, co. galway H53 K 8P4; EI H53 K8P4
• MDR Report Key: 5589985
• Report Number: 3005994106-2015-00004
• Device Sequence Number: 251216
• Product Code: DQY
• UDI-Device Identifier: 05391525781600
• UDI-Public: 05391525781600
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K102645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2016

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: Physician
• Device Expiration Date: 09/02/2018
• Device Model Number: PASSEO-35 HP 10/40/75
• Device Catalogue Number: 399096
• Device Lot Number: 21500053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2015
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/14/2015
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2016
• Supplement Report FDA Received Date: 05/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR