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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS
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ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number PTAX4-14-170-3-2
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/06/2015
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 of the advance 14 lp low profile balloon catheter detached from the shaft while the protective sleeve was being removed.There were no injuries or additional procedures reported.
 
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Brand Name
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
Common Device Name
DQY CATHETER, PERCUTANEOUS
MDR Report Key7588604
Report Number1820334-2018-01776
Device Sequence Number233152
Product Code DQY
UDI-Device Identifier10827002503271
UDI-Public(01)10827002503271(17)170913(10)NS5282104
Combination Product (Y/N)N
Initial Reporter CountryIN
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/11/2018
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 NumberPTAX4-14-170-3-2
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/06/2018
Initial Report FDA Received Date06/11/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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