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	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All of the batch documentation was reviewed and no issues were noted.The batch was manufactured accordingly to the correct validated process.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.All operators that worked on the batch in question were fully trained on their respective work steps.No unusual anomalies were noted in the fallout from the batch.The unit is being returned to the manufacturer for further investigation.A follow up report will be submitted from the resulting investigation.
Event or Problem Description
Procedure was smooth until deflation and withdrawal from sheath.Balloon wings did not rewrap well and got stuck at the sheath.Doctor requested product investigation and report.Product will be returned to the manufacturer for investigation.

• 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: 6661125
• Report Number: 3005994106-2017-00002
• Device Sequence Number: 45952
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2017

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: Physician
• Device Expiration Date: 09/06/2019
• Device Model Number: PASSEO-35 HP 10/40/75
• Device Catalogue Number: 399096
• Device Lot Number: 21601407
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 06/22/2017
• 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