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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS
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COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number PTA5-35-80-6-10.0
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/11/2017
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 information received indicated that the balloon burst before optimum pressure.The balloon was removed, a new balloon was opened and used.A piece of the device did not remain in the patient, the event did not require an additional procedure and there were no reported adverse effects to the patient as a result of the issue.
 
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Brand Name
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
Common Device Name
DQY CATHETER, PERCUTANEOUS
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key6711066
Report Number1820334-2017-01852
Device Sequence Number13701132
Product Code DQY
UDI-Device Identifier10827002523484
UDI-Public(01)10827002523484(17)171211(10)5508646
Combination Product (Y/N)N
Initial Reporter CountrySN
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/13/2017
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 Catalogue NumberPTA5-35-80-6-10.0
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/28/2017
Initial Report FDA Received Date07/13/2017
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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