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

Model Number 2200-3010

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problems Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Foreign Body In Patient (2687)

Event Date 07/22/2021

Event Type  Death  

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 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
• Type of Device: CATHETER, PTCA, 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: 12321170
• MDR Text Key: 266493270
• Report Number: 3005462046-2021-00050
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 00813132021207
• UDI-Public: 00813132021207
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC: 0.014" CHOICE PT GUIDEWIRE; EBU GUIDE CATHETER MFG AND SIZE UNK; TERUMO: 6F INTRODUCER SHEATH
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 55