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U.S. Department of Health and Human Services

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

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COOK INC ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number G30830
Device Problem Material Separation (1562)
Patient Problem No Code Available (3191)
Event Date 09/03/2020
Event Type  Injury  
Manufacturer Narrative
(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, during a superficial femoral and tibial atherectomy procedure with stent placement, involving a patient is his seventies, an advance 18 lp low profile pta balloon dilatation catheter separated. Access was obtained in the tibial vessel via the ankle. The vessels were reportedly extremely calcified. A cook 6 x 20 balloon was used first; however that device ruptured circumferentially. The ruptured 6 x 20 balloon will be reported under patient identifier (b)(6). The complaint device was then inserted via groin access to prevent bleeding. The balloon reportedly became mangled and separated. The user attempted to remove the separated portion with a snare, but was unsuccessful. The separated portion of the device was then stented in place. Reportedly, the tibial artery was tied off. The physician speculated that calcification was a contributing factor. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. Additional information has been requested, but is unavailable at this time.
 
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Brand NameADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION 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 Key10529259
MDR Text Key207198662
Report Number1820334-2020-01681
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG30830
Device Catalogue NumberPTAX4-18-170-3-15
Device Lot Number10168107
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2019
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: 09/14/2020 Patient Sequence Number: 1
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