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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
Catalog Number PTA5-35-80-5-4.0
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/23/2015
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
The balloon did not inflate during an sfa (superficial femoral artery) procedure and after checking injecting liquid out of the patient, it was noted that the catheter lost liquid.It was further confirmed that there was a pinhole leak in the balloon.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand Name
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
Common Device Name
DQY CATHETER, PERCUTANEOUS
MDR Report Key6714975
Report Number1820334-2017-01947
Device Sequence Number10992819
Product Code DQY
UDI-Device Identifier10827002523385
UDI-Public(01)10827002523385(17)171223(10)5537837
Combination Product (Y/N)N
Initial Reporter CountryES
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
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 Catalogue NumberPTA5-35-80-5-4.0
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/11/2017
Initial Report FDA Received Date07/14/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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