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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 G30949
Device Problems Material Rupture (1546); Material Separation (1562)
Patient Problems Foreign Body In Patient (2687); No Code Available (3191)
Event Date 12/03/2019
Event Type  Injury  
Manufacturer Narrative

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

As reported, during an unspecified procedure of the popliteal artery involving a patient with a history of peripheral artery disease, an advance 18 lp low profile balloon catheter ruptured circumferentially and separated. A 6 french cook ansel sheath was used and an unknown inflation device was used to inflate the balloon one time using omnipaque contrast, to approximately six atmospheres, when the balloon ruptured and separated. Reportedly, a pre-dilation with another manufacturer's balloon occurred prior to using the complaint device. The anatomy was reported to be heavily calcified, and the above-the-knee popliteal lesion was approximately 99% occluded. Tortuosity was not reported. The device was not inflated inside a stent prior to rupture. The distal end of the balloon remained in the patient, as the physician was unable to remove it. The physician stented the balloon in place. 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
jennifer canada
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key9437629
MDR Text Key170643832
Report Number1820334-2019-03041
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 01/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/09/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/17/2021
Device MODEL NumberG30949
Device Catalogue NumberPTA4-18-150-4-12
Device LOT Number9022392
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/10/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/17/2018
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: 12/09/2019 Patient Sequence Number: 1
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