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

Model Number 2200-2010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 02/14/2020

Event Type  Injury  

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 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 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.

Manufacturer Narrative

Block b5: updated to include patient outcome.H3 other text : placeholder.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Type of Device: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• MDR Report Key: 9863013
• MDR Text Key: 185505452
• Report Number: 3005462046-2020-00004
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 00813132021146
• UDI-Public: 00813132021146
• Combination Product (y/n): Y
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT: 0.014" BMW GUIDEWIRE; MERIT MEDICAL: 6F INTRODUCER SHEATH; UNK MFG: 6F GUIDE CATHETER
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR
• Patient Weight: 77