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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 G34325
Device Problems Material Rupture (1546); Material Separation (1562)
Patient Problem No Code Available (3191)
Event Date 10/15/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant products
=
cook kcfw-6. 0-35-55-rb-hfanl0-hc sheath, boston scientific v-18 control wire m00146850. (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
As reported, an advance 18 lp low profile balloon catheter ruptured and separated during an angiogram. The balloon was inflated one time, using an unknown inflation device, to eight atmospheres within the popliteal artery when it ruptured within thirty seconds. As the physician was pulling the balloon from the patient, it became caught on a 6 french cook sheath. Because the balloon was unable to be pulled through the sheath, the user removed the balloon, sheath, and other manufacturer's wire from the patient as a unit. A radiopaque marker remained visible on fluoroscopy after the device was removed. The marker, with a portion of the separated balloon material attached, was retrieved from the patient with a hemostat. A ct scan was performed and no additional balloon fragments were found in the patient. The anatomy was not angulated, tortuous or calcified. Blood was not noted in the inflation device. The balloon was not inflated within a stent. A counter-clockwise rotation of the device was not conducted upon removal. Initially, the user had intended to place a stent during the procedure, but elected to bring the patient back at a later date to do so. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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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
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key10726058
MDR Text Key212723375
Report Number1820334-2020-01924
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130293
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG34325
Device Catalogue NumberPTA4-18-150-4-6
Device Lot Number13202447
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2020
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: 10/23/2020 Patient Sequence Number: 1
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