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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; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number PTA5-35-80-5-20.0
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/10/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol_(b)(4), compliant/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event or Problem Description
When inflating the balloon it leaked with low pressure.During the procedure the balloon burst before 10 bars of pressure was reached.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
LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key6706165
Report Number1820334-2017-01848
Device Sequence Number19025633
Product Code LIT
UDI-Device Identifier10827002343594
UDI-Public(01)10827002343594(17)191201(10)7481900
Combination Product (Y/N)N
Initial Reporter CountryFI
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/12/2017
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 NumberPTA5-35-80-5-20.0
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/28/2017
Initial Report FDA Received Date07/12/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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