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

Model Number	399097
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
An 8f 45cm arrow sheath was used to introduce the balloon.A cook roadrunner 035 system 180cm wire was used to guide the balloon to the lesion.A passeo-35 4/60/90 balloon was used to pre-dilate the lesion in the subclavian vein.After pre-dilation, the passeo-35hp 12/40/75 balloon was introduced to further dilate the vessel.Balloon was inflated through the 8f 45cm arrow sheath and deflated after 2 minutes at 18atm pressure.When balloon was about to be removed from the sheath, physician experienced difficulty in pulling the balloon out, despite using force.After numerous attempts, physician removed the sheath along with the balloon and revealed the balloon was stuck at the distal opening of the sheath as balloon did not deflate and rewrap properly.

• Brand Name: PASSEO-35HP
• Common Device Name: PTA BALLOON CATHETER
• Manufacturer (Section D): CREAGH MEDICAL LTD.; ida business park; ballinasloe, galway H53 K 8P4; EI H53 K8P4
• MDR Report Key: 10258894
• Report Number: 3005994106-2020-00058
• Device Sequence Number: 485128
• Product Code: LIT
• UDI-Device Identifier: 05391525781617
• UDI-Public: 05391525781617
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K113468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2020

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: Health Professional
• Device Model Number: 399097
• Device Catalogue Number: 399097
• Device Lot Number: 21800818
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 07/10/2020
• 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