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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS
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ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS Back to Search Results
Model Number G52279
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/05/2015
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event or Problem Description
It was reported that the balloon was inflated to 8 atm and it ruptured in the common femoral artery.The vessel was "lightly" calcified and the procedure was successfully completed with another device of the same type.There were no reports of adverse effects to the patient as a result of this product problem.
 
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Brand Name
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
Common Device Name
DQY CATHETER, PERCUTANEOUS
MDR Report Key6718759
Report Number1820334-2017-01957
Device Sequence Number832150
Product Code DQY
UDI-Device Identifier10827002522791
UDI-Public(01)10827002522791(17)150801(10)3639609
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/17/2017
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 NumberG52279
Device Catalogue NumberPTA5-35-135-8-4.0
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/11/2017
Initial Report FDA Received Date07/17/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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