MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION QUICKCAT EXTRACTION KIT

Model Number	60090-01
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Codes	Death (1802); Ventricular Fibrillation (2130); Cardiogenic Shock (2262); Foreign Body In Patient (2687)
Date of Event	08/31/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device evaluation: the device was evaluated on 27 september 2018.During evaluation it was observed that 35 cm from the distal end of the catheter was missing.The break was at a fuse joint and appeared to be a semi-shear break.A portion of the distal tubing was still attached.Additional device evaluation is pending.
Event or Problem Description
During a cardiac lead management surgery, mechanical aspiration was performed in proximal left anterior descending artery (lad) and the second diagonal branch, with retrieval of moderate amounts of thrombotic debris.However, during retrieval, the quickcat aspiration catheter and another manufacturer's guide wire snapped, leaving portions of the quickcat and guide wire within the d2 branch of the lad.Multiple attempts were made to retrieve the portions, using a snare, without success.Another quickcat catheter was used to attempt further aspiration of emboli from the area, after above event occurred.Patient was very ill prior to beginning the procedure (pre-existing cardiogenic shock, ventricular fibrillation).It was reported that the patient was being shocked (defibrillator used) during the procedure, and it is unknown if the devices were present in the patient during the time of defibrillation.The patient survived the procedure, but passed away the following day.
Additional Manufacturer Narrative
Corrected information: this was a coronary vascular intervention case, not a lead management case as first reported.Additional information - supplier device evaluation: portion of quickcat device was sent from the manufacturer to the supplier, who manufactures/assembles the quickcat device at the fuse joint, where the catheter broke in this event.Device was returned to the supplier and received on 24 october 2018.An investigation took place, including actual device portion examination and investigation, dhr history, and pull testing.Stretching of the nylon section of the device at the fuse joint was observed, expected when excessive force is used, as during the supplier's destructive pull test.There was no sign of the material damage.The root cause could not be confirmed; however, there is no indication that the incident was caused by a supplier manufacturing process failure.The supplier's summary report was received by spectranetics on 27 nov 2018.
Event or Problem Description
This was a coronary vascular intervention procedure.

• Brand Name: QUICKCAT EXTRACTION KIT
• Common Device Name: QUICKCAT
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 7922781
• Report Number: 1721279-2018-00131
• Device Sequence Number: 16564897
• Product Code: DXE
• UDI-Device Identifier: 00813132020989
• UDI-Public: 00813132020989
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K073519
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2018
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2021
• Device Model Number: 60090-01
• Device Catalogue Number: 60090-01
• Device Lot Number: FQT18E09A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 55 YR
• Patient Weight: 162
• Date Report Sent to FDA: 01/01/2005