MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, PTCA, CUTTING/SCORING

Model Number	2200-2010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	02/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient developed a hematoma during use of the angiosculpt device.No device malfunction reported.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.The angiosculpt device was discarded, thus no product investigation was performed.Per the ifu, hematoma is listed as a potential complications/adverse events.
Event or Problem Description
The physician experienced difficulty accessing the groin, in order to treat a severely calcified mid lad.At the access site, the patient developed a hematoma and became hypotensive.When several balloons including the angiosculpt device failed to cross the lesion, the patient decompensated enough to justify stopping the case to address the groin issue.
Event or Problem Description
The patient was admitted to monitor the groin complication.After two nights, the patient had a positive outcome and was sent home.Two weeks post procedure, the physician indicated the patient is doing fine.
Additional Manufacturer Narrative
Block b5: updated to include patient outcome.H3 other text : placeholder.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Common Device Name: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• MDR Report Key: 9863013
• Report Number: 3005462046-2020-00004
• Device Sequence Number: 3432611
• Product Code: NWX
• UDI-Device Identifier: 00813132021146
• UDI-Public: 00813132021146
• Combination Product (Y/N): Y
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P050018
• Number of Events Summarized: 1
• Summary Report (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): 02/21/2020
• Report Date (Section F): 01/01/2005

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: 09/30/2022
• Device Model Number: 2200-2010
• Device Catalogue Number: 2200-2010
• Device Lot Number: G19090031
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 03/28/2020
• 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: ABBOTT: 0.014" BMW GUIDEWIRE; MERIT MEDICAL: 6F INTRODUCER SHEATH; UNK MFG: 6F GUIDE CATHETER
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 77 YR
• Patient Weight: 77
• Date Report Sent to FDA: 01/01/2005