MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS SLSII LASER CATHETER; DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS

Model Number	500-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Iatrogenic Source (2498)
Date of Event	08/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device lot number, expiration date unavailable.Device manufacture date unavailable because lot number unavailable.
Event or Problem Description
A lead extraction procedure commenced to remove a left ventricular (lv) lead due to non function.A right atrial (ra) and right ventricular (rv) lead were present in the patient, but were not targeted for extraction.A spectranetics lead locking device (lld) was inserted into the lv lead to act as a traction platform to aid in extraction.The physician chose to use a spectranetics 12f slsii laser sheath.The physician reportedly lased in the coronary sinus, near the ostium.The lv lead was successfully removed.However, the physician noted hemodynamic changes in the patient, ten minutes after the extraction was completed.Rescue efforts began immediately, including pericardiocentesis and sternotomy.A 2 cm injury was discovered, 1-2cm into the coronary sinus from the ostium.Based on the injury location and shape, the physician believes it was a combination of the scar tissue tearing away from the proximal coronary sinus along with laser use.The repair to the area was successful and the patient survived the procedure.This report is being submitted since the slsii device was reportedly lasing in the area of injury.There was no alleged malfunction of any spectranetics device in use during the procedure.

• Brand Name: SPECTRANETICS SLSII LASER CATHETER
• Common Device Name: DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 10473298
• Report Number: 1721279-2020-00179
• Device Sequence Number: 14051281
• Product Code: MFA
• UDI-Device Identifier: 00813132020293
• UDI-Public: 00813132020293
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P960042
• 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
• Report Date (Section B): 08/07/2020
• 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 Model Number: 500-001
• Device Catalogue Number: 500-001
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 08/31/2020
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 92
• Date Report Sent to FDA: 01/01/2005