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

Model Number	2249-50200
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The angiosculpt device was used in a peripheral lesion.Upon removal, the device could not be removed through the sheath, thus the device and sheath were removed together as a unit.A new sheath and non-angiosculpt device were used to complete the procedure.No patient injury reported.This adverse event is being reported because the angiosculpt got stuck on a non-manufacturer's introducer sheath and were removed as a unit.Placement of a new sheath was necessary to complete the procedure.
Additional Manufacturer Narrative
The angiosculpt device was not returned by the facility, thus no returned product investigation was performed.Per the ifu, if unusual resistance is felt when the catheter is being manipulated, carefully remove the entire catheter system.
Additional Manufacturer Narrative
Blocks d4/h4: the model number updated from 2076-6040 to 2249-50200.The lot number updated from g20020014 to g22050004.The expiration date updated from 2/14/2023 to 5/2/2024.The udi# updated from (b)(4) to (b)(4).The device manufacturer date updated from 2/14/2020 to 5/2/2022.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.
Additional Manufacturer Narrative
Blocks h3/h6: the angiosculpt device was returned intact to a 6f introducer sheath.Visual inspection confirmed the angiosculpt was partially inserted through the sheath with the distal scoring element bunched up.An attempt to remove the device through the 6f introducer sheath was performed; however, the bunching of the distal scoring element prevented the device from being removed from the sheath.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.

• Brand Name: ANGIOSCULPT OTW PTA
• Common Device Name: CATHETER, PTA, CUTTING/SCORING
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 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: 15033772
• Report Number: 3005462046-2022-00031
• Device Sequence Number: 17427837
• Product Code: PNO
• UDI-Device Identifier: 00813132021566
• UDI-Public: 00813132021566
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/02/2024
• Device Model Number: 2249-50200
• Device Catalogue Number: 2249-50200
• Device Lot Number: G22050004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/23/2022
• Supplement Date Received by Manufacturer: 08/02/2022; 08/02/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/12/2022; 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• 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: GUIDEWIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown