MAUDE Adverse Event Report: SPECTRANETICS CORPORATION ANGIOSCULPT OTW PTA SCORING BALLOON CATHETER; CATHETER, PERCUTANEOUS, CUTTING/SCORING

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	04/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2/a3/a4: the patient's dob or age at time of event, gender, and weight are unknown.This information was not available from the facility.Block b6: patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.Block g2: foreign- japan block h3: the angiosculpt device was discarded by the facility, thus no returned product investigation was performed.Block h6: the root cause cannot be determined since the device was not returned.However, based on the information available, the probable root cause may be due to failure to follow instructions.The angiosculpt device was inflated 2 atm above the rated burst pressure (rbp).The ifu warns that the balloon pressure should not exceed the rbp (14 atm) as indicated on the product label.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
The angiosculpt device was used to treat a severely calcified mid radial vein.During the second inflation at 16 atm, the balloon ruptured.The procedure was completed with a non-angiosculpt device.No patient injury reported.This product problem is being submitted because the balloon ruptured above rbp (14 atm).There is potential for harm if it were to recur.

• Brand Name: ANGIOSCULPT OTW PTA SCORING BALLOON CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: diana melliza galvez ; 5055 brandin court; fremont, CA 94538 ; 510933-4541
• MDR Report Key: 19243831
• Report Number: 3005462046-2024-00013
• Device Sequence Number: 15310991
• Product Code: PNO
• UDI-Device Identifier: 00813132021412
• UDI-Public: (01)00813132021412(17)260928(10)G23090125
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2024

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 Date: 09/28/2026
• Device Model Number: 2092-5040
• Device Catalogue Number: 2092-5040
• Device Lot Number: G23090125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORDIS: VASSALLO GT GUIDEWIRE, UNK SIZE; MEDIKIT: 6F ULTRA HIGH FLOW INTRODUCER SHEATH; UNK MFG AND SIZE: GUIDE CATHETER
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian