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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 Problem No Code Available (3191)
Event Date 10/26/2020
Event Type  Injury  
Manufacturer Narrative
Reporter occupation: other non-healthcare professional: office manager. (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 percutaneous transluminal angioplasty of the left superficial femoral artery (sfa), an advance 18 lp low profile balloon catheter ruptured and separated. The patient¿s anatomy was extremely calcified; however, was not tortuous or angulated. The entire left sfa was diseased and eighty to ninety-five percent occluded, with a short (approximately 60mm) area of chronic total occlusion. The balloon was inflated three times to nominal pressure with an unknown inflation device and a 50/50 ratio of contrast to saline for approximately 30 to 40 seconds. The balloon did not go over burst pressure. The balloon was not removed and reinserted between inflations. After the balloon ruptured, the user attempted to pull the balloon off an unknown wire guide and into a cook sheath, using a counter-clockwise rotation; however, two-thirds of the balloon would not enter the sheath. The user continued to pull on the device and approximately ten to fifteen millimeters of the balloon separated and remained on the wire guide. A cook clover snare was then used to retrieve the separated portion of the balloon from the patient, via the left groin. The balloon was not inflated within a stent. Negative pressie was not maintained continuously during removal of the complaint device, as blood was noted in the inflation device.
 
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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 Key10828186
MDR Text Key215956071
Report Number1820334-2020-02077
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 02/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG30958
Device Catalogue NumberPTA4-18-150-5-20
Device Lot Number13404239
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/02/2020
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: 11/12/2020 Patient Sequence Number: 1
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