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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW); CATHETER, PERCUTANEOUS, CUTTING/SCORING
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SPECTRANETICS ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW); CATHETER, PERCUTANEOUS, CUTTING/SCORING Back to Search Results
Model Number 2092-5040
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/17/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The patient's dob or age at time of event, gender, weight, ethnicity, and race are unknown.This information was not available from the facility.During inflation, the balloon ruptured below rbp.No patient injury, this mdr is being reported conservatively.Patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Report source: foreign (b)(6).The angiosculpt device was discarded by the facility, thus no returned product investigation was performed.(b)(4).
 
Event or Problem Description
The angiosculpt device was used to treat the mid cephalic vein and during inflation, the balloon ruptured at 10 atm.The procedure was completed with a non-angiosculpt device.No patient injury reported.
 
Additional Manufacturer Narrative
Block h6: added codes 419 (balloon) and 2199 (no health consequences or impact).
 
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Brand Name
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
Common Device Name
CATHETER, PERCUTANEOUS, CUTTING/SCORING
Manufacturer (Section D)
SPECTRANETICS
5055 brandin court
fremont CA 94538
MDR Report Key11935543
Report Number3005462046-2021-00031
Device Sequence Number17101606
Product Code PNO
UDI-Device Identifier00813132021412
UDI-Public00813132021412
Combination Product (Y/N)Y
Initial Reporter CountryJA
PMA/510(K) Number
K100303
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 05/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date10/26/2023
Device Model Number2092-5040
Device Catalogue Number2092-5040
Device Lot NumberG20100082
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 05/19/2021
Supplement Date Received by Manufacturer06/06/2021
Initial Report FDA Received Date06/03/2021
Supplement Report FDA Received Date06/10/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
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