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

Model Number	2200-3515
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's weight is unknown.This information was not available from the facility.During removal, the angiosculpt device separated in two pieces.Recurrence of the malfunction could result in patient harm.No patient injury reported.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.The angiosculpt device was returned for evaluation.Visual inspection found a missing distal tip and a device separation at the intermediate shaft, approximately 2 cm distal to the hypotube.Resistance was noted during delivery; however, the user proceeded to use the relevant device.Per the ifu, if unusual resistance is felt when the catheter is being manipulated, carefully remove the entire catheter system as a unit.
Event or Problem Description
It was reported that during a coronary procedure, resistance was noted during delivery of the angiosculpt device.Upon removal, the shaft broke in two pieces and the device was removed intact to the guide wire with no additional intervention.The procedure was aborted due to the patient not being a good candidate and the procedure was completed from an interventional standpoint.No patient injury reported.
Additional Manufacturer Narrative
Block h6: in the initial mdr, investigation conclusion code 61 was added.However, upon further review, it was determined that this code does not apply.The user followed the ifu and did not proceed with the relevant device when resistance was noted.

• Brand Name: ANGIOSCULPT RX PTCA
• Common Device Name: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• MDR Report Key: 11980177
• Report Number: 3005462046-2021-00034
• Device Sequence Number: 4015245
• Product Code: NWX
• UDI-Device Identifier: 00813132021245
• UDI-Public: 00813132021245
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2023
• Device Model Number: 2200-3515
• Device Catalogue Number: 2200-3515
• Device Lot Number: G20110057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 07/07/2021
• 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: ABBOTT: 6F INTRODUCER SHEATH; CORDIS: 6F GUIDE CATHETER; TERUMO: 0.014" GUIDE WIRE
• Patient Age: 69 YR