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

Model Number	2076-5040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
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.(b)(6).Angiosculpt device was returned for evaluation; however, the returned product investigation has not begun, thus a supplemental report will be filed upon completion.
Event or Problem Description
The angiosculpt device was used to treat a moderately tortuous vessel and a moderately calcified mid sfa.During the second inflation at 8 atm for 30 seconds, the balloon ruptured.The procedure was completed with a non-angiosculpt device.No patient injury reported.
Additional Manufacturer Narrative
Block g3/h3: the angiosculpt device was returned for evaluation.Block h3: visual inspection found no unusual characteristics of the device.During functional testing using an indeflator filled with green color dye water, the device was pressurized and at less than 2 atm, a balloon leak was present.Under microscopic inspection, a longitudinal balloon tear was observed.Block h6: the ifu warns at least 99.9% of the balloons (with a 95% confidence level) will not burst at or below the rbp.
Additional Manufacturer Narrative
Block b5: added "this product problem is being submitted conservatively because the balloon ruptured below rbp.".
Event or Problem Description
This product problem is being submitted conservatively because the balloon ruptured below rbp.

• Brand Name: ANGIOSCULPT OTW PTA
• Common Device Name: CATHETER, PTA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: ana tan ; 5055 brandin court; fremont, CA 94538
• MDR Report Key: 12817385
• Report Number: 3005462046-2021-00064
• Device Sequence Number: 4869328
• Product Code: PNO
• UDI-Device Identifier: 00813132021375
• UDI-Public: 00813132021375
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2021

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 Date: 09/23/2023
• Device Model Number: 2076-5040
• Device Catalogue Number: 2076-5040
• Device Lot Number: G20090031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 11/15/2021; 12/29/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 11/30/2021; 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2020
• 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: BOSTON SCIENTIFIC: 0.014" JUPITER GUIDEWIRE; TERUMO: 7F DESTINATION SHEATH/GUIDE
• Patient Sex: Unknown