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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number PTA4-18-80-6-20
Device Problem Insufficient Information (3190)
Patient Problems Calcium Deposits/Calcification (1758); Occlusion (1984)
Event Date 05/09/2016
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed. Blank fields on this form that have not been previously submitted indicate the information is unknown or unavailable.
 
Event Description
The complainant reported that the advance 18 lp low profile balloon catheter was advanced across a calcified lesion and inflated to 8 atm (atmospheres) without any problems. An angiogram displayed occlusion of the left sfa (superficial femoral artery) and popliteal vessel. The balloon was then pulled back and inflated for a second time to 8 atm (atmospheres) when the balloon ruptured. The device was successfully removed "otw" and was intact upon removal. The product problem did not result in any reported serious injuries to the patient.
 
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Brand NameADVANCE 18 LP LOW PROFILE BALLOON CATHETER
Type of DeviceLIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7747468
MDR Text Key116537094
Report Number1820334-2018-02385
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/01/2017
Device Catalogue NumberPTA4-18-80-6-20
Device Lot Number5017016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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