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	Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Top assembly batch history record was reviewed.The units were processed to the correct validated parameters by trained personnel.All units were 100% visually inspected and leak tested to a rated pressure of 20 atm.All operators that worked on the batches in question were fully trained on their respective work steps.There were no ncr's or planned deviations associated with the batches in question.No unusual anomalies were noted following the batch review.The unit was returned for further investigation and was confirmed as being correct (passeo 35 hp 10/40/75, batch # 21601407).Upon visual inspection,it was noted that the balloon had ruptured radially.The unit was also observed to be missing the top section of the balloon including the tip.The inner and both markerbands were also missing from the returned unit.It was not possible to test the unit further as the balloon has been damaged so severely.The cause of the issue is therefore inconclusive.It was noted from the complaint notification that the unit was inflated to 24 atm, which is above the device rated pressure of 20atm.
Event or Problem Description
During the treatment of a tight lesion of the central vein, the balloon ruptured radially into two parts.While withdrawing the tip dislodged and stuck at the neck of the stenosis and could not be removed.After 10 minutes thrombus developed at the lesion.Vascular surgeon assessed that migration of the device was not possible.Patient being monitored.

• 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: 6760939
• Report Number: 3005994106-2017-00004
• Device Sequence Number: 19263204
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 07/17/2017

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: Other
• Device Expiration Date: 09/06/2019
• Device Model Number: PASSEO-35 HP 10/40/75
• Device Catalogue Number: 399096
• Device Lot Number: 21601407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2017
• Initial 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