• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CREAGH MEDICAL LTD. HP PTA BALLON DILATATION CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CREAGH MEDICAL LTD. HP PTA BALLON DILATATION CATHETER Back to Search Results
Model Number UHP75124
Device Problem Material Rupture (1546)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  malfunction  
Event Description
Account reports balloon broke off while in patient's venous system in shoulder. User facility could not see piece broken off and sent patient across street to iu methodist hospital ct to identify where piece was and treated patient as necessary. The balloon inflated the first time to full pressure; it burst at about 6-8 atmospheres on the second inflation. The facility believes the fractured piece was lodged in the stent that was placed. The facility was going to attempt to snare or clip the piece out. Same patient, same brachial cephalic stent graft but came in from the left side today through the ij and was in a different location on the stent - essentially the other end of the stent. Upon asking for further information it became evident that they stent has been implanted and came in to contact with the metal stent and the contact ruptured the balloon.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHP
Type of DevicePTA BALLON DILATATION CATHETER
Manufacturer (Section D)
CREAGH MEDICAL LTD.
ida business park
ballinasloe, co. galway galway, H53 K 8P4
EI H53 K8P4
Manufacturer (Section G)
CREAGH MEDICAL LTD.
ida business park
balinasloe, co. galway, galway H53 K 8P4
EI H53 K8P4
Manufacturer Contact
jonathan canavan
ida business park
balinasloe, co. galway, galway H53 K-8P4
EI   H53 K8P4
MDR Report Key10148873
MDR Text Key213032440
Report Number3005994106-2020-00054
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113468
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUHP75124
Device Catalogue NumberUHP75124
Device Lot Number21904076
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/12/2020 Patient Sequence Number: 1
-
-