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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
Model Number G30958
Device Problems Material Rupture (1546); Material Separation (1562)
Patient Problems Foreign Body In Patient (2687); No Code Available (3191)
Event Date 01/09/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant devices: cook sphere inflation device,. 014" csi viper wire. Pma/510(k) number
=
k130293. (b)(4). This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
 
Event Description
It was reported, during the initial inflation inside the patient's anatomy, the advance 18 lp low profile balloon catheter ruptured circumferentially prior to reaching nominal pressure. Inflation pressure was reported as approximately 7 atmospheres(atm). Reportedly, the male patient was undergoing peripheral angioplasty of a lesion in the distal to mid superficial femoral artery. Access was obtained in the left common femoral artery treating the right leg. The patient's anatomy was calcified but not angulated. Mixture of contrast to saline is unknown but the fluid was still in place inside the complaint device at the time of rupture. Subsequently, the physician attempted to back the complaint device out of the patient's anatomy through the sheath; however, it became stuck on the guide wire. A clockwise rotation was not used during removal. Both the wire and complaint device were then removed together. During removal, a portion of the complaint device broke off and remained inside the patient's anatomy. Unsuccessful attempts were made to remove this portion using "a wire, catheter, suction and snares". The retained portion was surgically removed on (b)(6) 2019. Reportedly, the patient is doing fine.
 
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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
8123392235
MDR Report Key8253275
MDR Text Key133239330
Report Number1820334-2019-00138
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/05/2021
Device Model NumberG30958
Device Catalogue NumberPTA4-18-150-5-20
Device Lot Number9138775
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2018
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: 01/16/2019 Patient Sequence Number: 1
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