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	12/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The angiosculpt device was used to treat a severely calcified mid iliac.During the 4th inflation, the balloon ruptured at 14 atm.The procedure was completed with a non-angiosculpt device.No patient injury reported.This product problem is being submitted per fda request because the balloon ruptured at 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 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.
Additional Manufacturer Narrative
Block b5: updated from "this product problem is being submitted per fda request because the balloon ruptured at rbp" to "this product problem is being submitted conservatively because the balloon ruptured at rbp.".
Event or Problem Description
This product problem is being submitted conservatively because the balloon ruptured at 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: 13101352
• Report Number: 3005462046-2021-00075
• Device Sequence Number: 17067231
• 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
• Report Date (Section B): 12/10/2021

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: 03/24/2023
• Device Model Number: 2076-5040
• Device Catalogue Number: 2076-5040
• Device Lot Number: G20030018
• 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: 12/10/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• 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: MEDIKIT: 6F INTRODUCER SHEATH; TERUMO: 0.018" GUIDE WIRE
• Patient Sex: Unknown