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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 PTA5-35-135-5-20.0
Device Problem Balloon rupture
Event Date 11/04/2014
Event Type  Injury  
Event Description

The physician was pre-dilating the lesion with the balloon when the balloon ruptured. A part of the balloon broke off and one long fragment remained in the body of the male patient. An intervention during the same procedure was performed to retrieve the balloon fragment. They got wire access through and from both access points in the groin, were able to pull the fragment out through the sheat over the wire. They successfully completed the originally intended ballooning and stenting. The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

 
Manufacturer Narrative

(b)(4). Event is still under investigation.

 
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Brand NameADVANCE 35 LP LOW PROFILE BALLOON CATHETER
Type of DeviceLIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COOK, INC.
bloomington IN 47404
Manufacturer Contact
rita harden, director
750 daniels way
bloomington , IN 47404
8123392235
MDR Report Key4332028
Report Number1820334-2014-00627
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/10/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/05/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/01/2017
Device Catalogue NumberPTA5-35-135-5-20.0
Device LOT Number4906847
OTHER Device ID NumberUDI#: (01)10827002355320(17)
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer12/02/2014
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/04/2014
Device Age7 mo
Event Location Hospital
Date Manufacturer Received11/10/2014
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/05/2014 Patient Sequence Number: 1
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