MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT OTW PTA; CATHETER, PTA, 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	02/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The angiosculpt device was used to treat a moderately tortuous and severely calcified distal sfa.During inflation at 12 atm, the balloon ruptured.The procedure was completed with a new balloon.No patient injury reported.This product problem is being submitted conservatively because the balloon ruptured below rbp.
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.Patient information regarding relevant tests/laboratory data is 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.

• 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: diana melliza galvez ; 5055 brandin court; fremont, CA 94538
• MDR Report Key: 13660381
• Report Number: 3005462046-2022-00013
• Device Sequence Number: 12085964
• Product Code: PNO
• UDI-Device Identifier: 00813132021412
• UDI-Public: 00813132021412
• 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
• Report Date (Section B): 02/17/2022

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: 12/01/2023
• Device Model Number: 2092-5040
• Device Catalogue Number: 2092-5040
• Device Lot Number: G20120002
• Was Device Available for Evaluation?: No
• 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: 02/17/2022
• Initial Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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: CARDINAL HEALTH: 0.014" VASSALLO GUIDE WIRE; NIPRO: 6F CROSSROAD INTRODUCER SHEATH; UNK MFG AND SIZE: GUIDE CATHETER
• Patient Sex: Unknown