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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOSCORE, INC. ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) CATHETER, ANGIOPLASTY, PERIPHERAL

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ANGIOSCORE, INC. ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) CATHETER, ANGIOPLASTY, PERIPHERAL Back to Search Results
Model Number 2237-50100
Device Problems Wire (430); Break (1069)
Patient Problem No Information (3190)
Event Date 02/25/2015
Event Type  Injury  
Event Description

Angiosculpt device broke off in a patient. Used a 5f sheath in antegrade in the left leg. Performed multiple inflations with a 5x100 device. After catheter removal, noticed the wires were still in the distal sfa. Tried to snare the wires but unable to. Able to pull it up to where the sheath was and then decided to pull the sheath hoping that the wires were encased within the sheath. The wires did not come out. Had to hold manual pressure. Accessed the right side and went in with 8f, 45 cm crossover sheath. Advanced the ensnare and was able to retrieve the wires through the sheath.

 
Manufacturer Narrative

The patient's age or dob, gender, and weight are unknown. This information was not available from the facility. During withdrawal, the angiosculpt device separated in the patient. Additional intervention was required for removal, thus resulting in prolongation of the case. Visual examination confirmed the catheter separated at two locations. The distal tip, a mangled scoring element, and a portion of the transition tubing separated approximately 11. 7 cm proximal from the proximal bond. The separated ends of the transition tubing were uneven. The distal inner member separated at the distal tip seal bond. The inner member was stretched and pulled proximally causing the marker band to be displaced. The capture device was also returned intact to the 5f introducer sheath, which was located inside an 8f introducer sheath. The proximal end of the 5f introducer sheath was damaged. The physician used the angiosculpt device off-label. Per the ifu, a 5. 0 x 100 mm angiosculpt device is compatible with a 6f introducer sheath. It is probable that using an undersized sheath and the excessive exertion of force applied by the user observed during lab analysis may have caused or contributed to the separation. In addition, retained device component is listed as a possible adverse effect of the procedure. Placeholder.

 
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Brand NameANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL
Manufacturer (Section D)
ANGIOSCORE, INC.
fremont CA
Manufacturer (Section G)
ANGIOSCORE, INC.
Manufacturer Contact
florie cazem
5055 brandin court
fremont, CA 94538
510933-792
MDR Report Key4620646
MDR Text Key5762374
Report Number3005462046-2015-00010
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK112182
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 02/26/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/20/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/05/2017
Device MODEL Number2237-50100
Device Catalogue Number2237-50100
Device LOT NumberF14110005
OTHER Device ID NumberM37022375010018
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/12/2015
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/26/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/24/2014
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: 03/20/2015 Patient Sequence Number: 1
Treatment
UNK MFG: 0.014" GUIDE WIRE; UNK MFG:5F INTRODUCER SHEATH
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