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

Model Number	2092-5040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Embolism/Embolus (4438); Thrombosis/Thrombus (4440)
Date of Event	07/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's date of birth, age, and weight are unknown.This information was not available from the facility.The patient experienced a thrombus occlusion and required intervention.Patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Foreign report source: (b)(6).The angiosculpt device was discarded by the facility, thus no returned product investigation was performed.Per the ifu, thrombus is listed under possible adverse effects.
Event or Problem Description
The angiosculpt device was used to treat a peripheral lesion on (b)(6) 2021 with no issues reported.However, the following day the patient experienced a thrombus occlusion in the ulnar artery and required intervention.The patient was treated with an ultraverse catheter with no patient problem reported.
Additional Manufacturer Narrative
Block b5: updated event details to add embolization.Block h6: added code to capture embolization.
Event or Problem Description
The angiosculpt device was used to treat a peripheral lesion on (b)(6) 2021 with no issues reported.However, the following day the patient experienced a thrombus occlusion and embolization in the ulnar artery and required intervention.The patient was treated with an ultraverse catheter with no patient problem reported.

• Brand Name: ANGIOSCULPT OTW PTA
• Common Device Name: CATHETER, PTA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• MDR Report Key: 12264339
• Report Number: 3005462046-2021-00046
• Device Sequence Number: 12012463
• Product Code: PNO
• UDI-Device Identifier: 00813132021412
• UDI-Public: 00813132021412
• Combination Product (Y/N): Y
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: 10/26/2023
• Device Model Number: 2092-5040
• Device Catalogue Number: 2092-5040
• Device Lot Number: G20100082
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention