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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

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COOK, INC. ADVANCE 35 LP LOW PROFILE BALLOON CATHETER Back to Search Results
Catalog Number PTA5-35-80-10-2.0
Device Problem Balloon rupture
Event Date 05/21/2014
Event Type  Injury  
Event Description

During a thrombectomy fistulogram on a (b)(6) male patient, hand inflation was used to inflate all of the balloons in this procedure. The first balloon went through the sheath one time and was used successfully once. They attempted to use the first balloon again and it would not reenter the sheath. They attempted to rewrap the balloon but it would not go into the sheath. They then opened a second balloon. The second balloon went through the sheath one time and was used successfully once. They attempted to use the second balloon again and it would not reenter the sheath. They attempted to rewrap the balloon but it would not go into the sheath. They then opened a third balloon. This balloon ruptured during its second inflation. Balloon fragments remained inside the patient's right axillary vein. A stent was used to tack the balloon fragments to the vessel wall so that the fragments don't cause harm to the patient.

 
Manufacturer Narrative

(b)(4).

 
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Brand NameADVANCE 35 LP LOW PROFILE BALLOON CATHETER
Manufacturer (Section D)
COOK, INC.
bloomington IN 47404
Manufacturer Contact
rita harden, dir
750 daniels way
bloomington , IN 47404
8122392235
MDR Report Key3894097
Report Number1820334-2014-00252
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 05/21/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/20/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2017
Device Catalogue NumberPTA5-35-80-10-2.0
Device LOT Number4783386
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer06/03/2014
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/21/2014
Device Age3 mo
Event Location Hospital
Date Manufacturer Received05/22/2014
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/17/2014
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: 06/20/2014 Patient Sequence Number: 1
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