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

Model Number 399097

Device Problem Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event 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
• Type of Device: PTA BALLOON CATHETER
• Manufacturer (Section D): CREAGH MEDICAL LTD.; ida business park; ballinasloe, galway H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL LTD.; ida business park; ballinasloe, galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: jonathan canavan ; ida business park; ballinasloe, galway H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 10258894
• MDR Text Key: 213032521
• Report Number: 3005994106-2020-00058
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 05391525781617
• UDI-Public: 05391525781617
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K113468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 399097
• Device Catalogue Number: 399097
• Device Lot Number: 21800818
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention