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

Model Number	2200-3010
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Foreign Body In Patient (2687)
Date of Event	07/22/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The angiosculpt device was lost at the customer site and was not returned, thus returned product investigation was not performed.Per the ifu, death is listed as a possible adverse effect.
Event or Problem Description
The physician treated a patient with multiple medical comorbidities and severely calcified lesions.After atherectomy with a rota wire and 1.5 mm burr, the guidewire was exchanged for a choice pt and the angiosculpt was delivered with not much resistance.The angiosculpt was inflated two times; one at 8 atm (nominal pressure) for five seconds, second inflation at 10 atm for 5 seconds.The balloon was able to deflate with no issues.Upon removal, the angiosculpt got caught on the patient's anatomy.The physician attempted to pull several times with the guide catheter being deep throated without success.Another wire passed the stuck angiosculpt and was placed in a diagonal position.Then, another balloon was advanced passed the angiosculpt partly inflated to try and dislodge the angiosculpt without success.The physician finally tugged on the shaft, and the shaft broke inside the patient and tried snaring it without success.By this time the patient started to decompensate, dropping bp, dropping o2 saturation, and code was started.Dye was injected, but did not see a perforation.It is likely that the patient developed global ischemia from the 3 vessel coronary disease as he was not a candidate for surgery or hemodynamic support.In retrospect, the physician suspected that the angiosculpt scoring element got imbedded in the calcific plaque, despite using rotational atherectomy in the vessel prior to the balloon angioplasty.The patient expired.This adverse event and product problem is being submitted because the distal portion of the shaft was retained in the patient.Additional intervention for device removal was performed; however, the patient expired during the procedure.

• Brand Name: ANGIOSCULPT RX PTCA
• Common Device Name: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 5055 brandin court; fremont CA 94538
• MDR Report Key: 12321170
• Report Number: 3005462046-2021-00050
• Device Sequence Number: 4157983
• Product Code: NWX
• UDI-Device Identifier: 00813132021207
• UDI-Public: 00813132021207
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/21/2024
• Device Model Number: 2200-3010
• Device Catalogue Number: 2200-3010
• Device Lot Number: G21040069
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/13/2021
• 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: BOSTON SCIENTIFIC: 0.014" CHOICE PT GUIDEWIRE; EBU GUIDE CATHETER MFG AND SIZE UNK; TERUMO: 6F INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 55