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

Model Number	PASSEO-35 HP12/40/75
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the internal investigation carried out at creagh medical the complaint has been confirmed.It was found that the unit in question had a "bunched appearance" around the distal end up to the marker band.Functional testing performed at creagh medical on the returned unit has proven successful when re-inserting the balloon into an 8fr introducer.The "bunching" defect could be re-created on a retained unit of identical size and specification by not fully deflating the balloon and not maintaining the vacuum prior to re-inserting into the introducer.This unit was manufactured accordingly to the correct validated process.All of the batch documentation and sub-assembly documentation was reviewed and no issues were noted.All operators that worked on the batchin 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 the device itself.
Event or Problem Description
The passeo-35 hp 12*40*75 catheter cannot re-enter into the 8fr sheath after 1st inflation.Physician had no choice but to change to 9fr sheath for the second time entry by using the same balloon.
Additional Manufacturer Narrative
Based on the internal investigation carried out at creagh medical the complaint has been confirmed.It was found that the unit in question had a "bunched appearance" around the distal end up to the marker band.Functional testing performed at creagh medical on the returned unit has proven successful when re-inserting the balloon into an 8fr introducer.The "bunching" defect could be re-created on a retained unit of identical size and specification by not fully deflating the balloon and not maintaining the vacuum prior to re-inserting into the introducer.This unit was manufactured accordingly to the correct validated process.All of the batch documentation and sub-assembly documentation was reviewed and no issues were noted.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 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 the device itself.
Event or Problem Description
The passeo-35 hp 12*40*75 catheter cannot re-enter into the 8fr sheath after 1st inflation.Physician had no choice but to change to 9fr sheath for the second time entry by using the same balloon.

• 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: 5588710
• Report Number: 3005994106-2015-00002
• Device Sequence Number: 16223584
• Product Code: DQY
• UDI-Device Identifier: 05391525781617
• UDI-Public: 05391525781617
• 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): 04/14/2016

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: 09/02/2018
• Device Model Number: PASSEO-35 HP12/40/75
• Device Catalogue Number: 399097
• Device Lot Number: 21500054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2015
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/30/2015
• 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
• Patient Age: 70 YR