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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, PTCA, CUTTING/SCORING

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SPECTRANETICS ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, PTCA, CUTTING/SCORING Back to Search Results
Model Number 2200-3510
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Injury (2348)
Event Date 10/09/2020
Event Type  Injury  
Manufacturer Narrative
The patient's dob or age at time of event, weight, ethnicity, and race are unknown.Attempts to obtain the information has not been successful.During withdrawal, the angiosculpt device separated in two pieces.Additional intervention was performed, resulting in a prolonged procedure.Patient information regarding relevant tests/laboratory data, or medical history is unknown.Attempts to obtain the information has not been successful.The angiosculpt device was not returned and kept at the facility for internal investigations.Although no piece of the angiosculpt device was left in the patient, retained device component is listed in the ifu as a possible adverse effect of the procedure.
 
Event Description
The angiosculpt device was delivered to the lesion with no resistance.Using an endoflator, negatived air was applied and blood was observed on the endoflator.During removal, the proximal shaft separated inside the guide catheter; therefore, the device was removed as a unit.Rewiring of the lesion was required to complete the procedure with a new angiosculpt device.No patient injury reported.
 
Manufacturer Narrative
Block d11: guide catheter size was updated from unk to 6f.
 
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Brand Name
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
Type of Device
CATHETER, PTCA, CUTTING/SCORING
Manufacturer (Section D)
SPECTRANETICS
5055 brandin court
fremont CA 94538
MDR Report Key10801170
MDR Text Key215045826
Report Number3005462046-2020-00048
Device Sequence Number1
Product Code NWX
UDI-Device Identifier00813132021238
UDI-Public00813132021238
Combination Product (y/n)Y
PMA/PMN Number
P050018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/08/2022
Device Model Number2200-3510
Device Catalogue Number2200-3510
Device Lot NumberG19110006
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/06/2020
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ABBOTT: 0.014" PILOT GUIDE WIRE; CORDIS: 6F GUIDE CATHETER; CORDIS: GUIDE CATHETER SIZE UNK; TERUMO: 6F SLENDER INTRODUCER SHEATH; ABBOTT: 0.014" PILOT GUIDE WIRE; CORDIS: GUIDE CATHETER SIZE UNK; TERUMO: 6F SLENDER INTRODUCER SHEATH
Patient Outcome(s) Hospitalization; Required Intervention;
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