MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT RX PTCA; CATHETER, PTCA, CUTTING/SCORING

Model Number	2200-2510
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's weight, ethnicity, and race are unknown.This information was not available from the facility.The 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 severely calcified proximal rca.During inflation, the balloon ruptured at 14 atm despite the burst rate of 20 atm per the ifu.The procedure was completed with a non-angiosculpt device.No patient injury reported.This product problem is being submitted conservatively because the balloon ruptured below rbp.
Additional Manufacturer Narrative
Block b5: this event is no longer reportable based on the observations from the returned product analysis.No balloon rupture was observed as described in the complaint details.
Event or Problem Description
Initial mdr reported a balloon rupture below rbp.However, based on the observations from the returned product analysis, no balloon rupture was observed as described in the complaint details.Therefore, this event is no longer reportable.
Additional Manufacturer Narrative
Block h2/h6: visual inspection found a lacerated distal shaft opposite side of the rx port.During functional testing, using an indeflator filled with green color dye water, the device was pressurized and at less than 2 atm, a distal shaft leak was observed on the opposite side of the rx port.Based on the lab analysis, the reported complaint of a balloon rupture could not be replicated; however, a shaft leak was noted.Per the manufacturer's work instruction, a shaft leak is not considered a reportable event.Supplemental report #1 submitted on 12/7/2021 was corrected to no longer reportable.

• Brand Name: ANGIOSCULPT RX PTCA
• Common Device Name: CATHETER, PTCA, 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: 12862818
• Report Number: 3005462046-2021-00070
• Device Sequence Number: 14532358
• Product Code: NWX
• UDI-Device Identifier: 00813132021177
• UDI-Public: 00813132021177
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P050018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2021

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: 06/11/2024
• Device Model Number: 2200-2510
• Device Catalogue Number: 2200-2510
• Device Lot Number: G21060033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• 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: 11/01/2021
• Supplement Date Received by Manufacturer: 12/01/2021; 12/01/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/07/2021; 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2021
• 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: UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Age: 73 YR
• Patient Sex: Male