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

Model Number	PASSEO-35 HP 6/60/75
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following a detailed device analysis, it was noted that the condition of the returned unit was consistent with the complaint incident.The 100% online inspections which were completed verify the inflation and deflation capabilities of each balloon catheter.If a balloon catheter was not capable of deflation this would be detected online during the inspection processes.The root cause of this issue is inconclusive but most probable root cause is operational context.There is adequate controls within creagh medical manufacturing system to detect catheters that do not deflate.
Event or Problem Description
Indication for treatment: hyperpressure of an av access.Treated artery: basilic vein the balloon didn't deflate.It was tried to change the inflation device, but the same problem occured with another one.

• Brand Name: PASSEO-35 HP
• Common Device Name: BALLOON DILATATION CATHETER
• Manufacturer (Section D): CREAGH MEDICAL LTD; ida industrial est.; ballonasloe; n/a, co. galway H53 K 8P4; EI H53 K8P4
• MDR Report Key: 5587514
• Report Number: 3005994106-2015-00003
• Device Sequence Number: 88522
• Product Code: LIT
• UDI-Device Identifier: 05391525781495
• UDI-Public: 05391525781495
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• 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: Other
• Device Expiration Date: 03/02/2017
• Device Model Number: PASSEO-35 HP 6/60/75
• Device Catalogue Number: 399085
• Device Lot Number: 21400144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2015
• Initial Report FDA Received Date: 04/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR