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

Model Number	PASSEO-35 HP 8/40/75
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Top assembly batch history record was reviewed.The units were processed to the correct validated parameters.All units were 100% visually inspected and leak tested to a rated pressure of 22 atm.All operators that worked on the batch in question were fully trained on their respective work steps.The material and components used in this device were determined to be consistent with all materials used in the manufacture of all uhp products.There were no ncr's or deviations associated with the batch in question.No unusual anomalies were noted following the batch review.Once the device is returned, further investigation will be carried out to determine the root cause.
Event or Problem Description
Balloon ruptured at 22atm during inflation.
Additional Manufacturer Narrative
Top assembly batch history record was reviewed.The units were processed to the correct validated parameters.All units were 100% visually inspected and leak tested to a rated pressure of 22 atm.All operators that worked on the batch in question were fully trained on their respective work steps.The material and components used in this device were determined to be consistent with all materials used in the manufacture of all uhp products.There were no ncr's or deviations associated with the batch in question.No unusual anomalies were noted following the batch review.This unit was manufactured using sub-assembly balloon batch # 21600815.All balloon batches are subjected to burst & compliance batch release testing.This batch met all statistical batch release requirements.The returned unit was confirmed as passeo 35hp 8/40/75, batch #.The balloon on the device had ruptured longitudinally.The markerbands were inspected under a 10x vision system and there were no visible defects noted which could have contributed to the burst.It was not possible to test the unit further as the balloon has been damaged so severely.
Event or Problem Description
Balloon ruptured at 22 atm during inflation.

• Brand Name: PASSEO-35 HP
• Common Device Name: BALLOON DILATATION CATHETER
• Manufacturer (Section D): CREAGH MEDICAL; ida business park; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• MDR Report Key: 6701933
• Report Number: 3005994106-2017-00003
• Device Sequence Number: 1570368
• Product Code: DQY
• UDI-Device Identifier: 05391525781563
• UDI-Public: 05391525781563
• 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,Followup
• Report Date (Section B): 06/26/2017

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: 08/21/2019
• Device Model Number: PASSEO-35 HP 8/40/75
• Device Catalogue Number: 399092
• Device Lot Number: 21601318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 08/02/2017
• 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