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

Model Number	2249-60200
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's dob or age at time of event, 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.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.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.
Event or Problem Description
The angiosculpt device was used in a moderately calcified mid sfa in-stent stenosis.The wire crossed the lesion and a 2.0 laser was used.When the angiosculpt was inserted, the device fully inflated and deflated with no issues.As the device was being removed, it was noticed that there was a kink halfway across the balloon and the scoring element appeared unorganized, preventing removal from the 6f sheath.Therefore, the device and sheath were removed together as a unit, keeping the guidewire in place.A new 6f sheath was inserted over the wire for hemostasis and an angiogram was performed after the sheath exchange to verify no bleeding.There was no injury to the vessel after the angiogram was performed.This adverse event is being reported because the angiosculpt got stuck inside 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
Block h3: the angiosculpt device was returned intact to an introducer sheath.Visual inspection found a kink on the proximal portion of the balloon and a damaged scoring element.Additionally, a distal bond peel was observed with 4 leaflets lifted, but remained intact to the device.During functional testing, an attempt to remove the catheter from the introducer sheath was performed, but unable due to resistance noted.Block h6: in the initial mdr, investigation conclusions code #22 (known inherent risk of device) was listed and remains appropriate.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: 15522051
• Report Number: 3005462046-2022-00049
• Device Sequence Number: 14080149
• Product Code: PNO
• UDI-Device Identifier: 00813132021573
• UDI-Public: 00813132021573
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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: 05/11/2024
• Device Model Number: 2249-60200
• Device Catalogue Number: 2249-60200
• Device Lot Number: G22050046
• 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: 09/02/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2022
• 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: ABBOTT: 0.014" CONFIANZA GUIDEWIRE.; TERUMO: 6F PRELUDE INTRODUCER SHEATH.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female