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U.S. Department of Health and Human Services

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

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CREAGH MEDICAL LTD. PASSEO-35HP PTA BALLOON CATHETER Back to Search Results
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.
 
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Brand NamePASSEO-35HP
Type of DevicePTA 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 Key10258894
MDR Text Key213032521
Report Number3005994106-2020-00058
Device Sequence Number1
Product Code LIT
UDI-Device Identifier05391525781617
UDI-Public05391525781617
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K113468
Number of Events Reported1
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 Received07/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number399097
Device Catalogue Number399097
Device Lot Number21800818
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/10/2020 Patient Sequence Number: 1
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