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

Model Number	500-013
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	10/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's date of birth unavailable.
Event or Problem Description
A lead extraction procedure commenced to remove a single coil right ventricular (rv) lead implanted in 2014.A spectranetics lead locking device (lld) was inserted into the rv to act as a traction platform to aid in extraction.The physician began the case using a spectranetics 14f glidelight laser sheath.He was able to progress to the subclavian/innominate region, and then, due to adhesions, he chose to use a spectranetics tightrail sub-c rotating dilator sheath.At this time, the lead looked like it was breaking apart and the physician chose to use a spectranetics 16f sls device.At that time the patient had drop in blood pressure.It was first thought that the rv was being inverted during traction, but pressure continued to drop when traction was released.Contrast was used to confirm the injury location; an innominate injury, 1cm in length, was discovered, 4-5cm lateral to the superior vena cava (svc).Rescue efforts commenced immediately, including sternotomy.The repair to the innominate vein was successful, and the patient survived the procedure.The rv lead was removed without issues post-sternotomy, with use of the 16f sls device.There was no alleged malfunction of any spectranetics device in use during the procedure.At the time the adverse event occurred in this procedure, it was discovered that at the time of implant of the rv lead in 2014, the physician performing the implant had gone into the subclavian vein, out of the vein, and back in the innominate vein and then implanted the rv lead.

• 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: 10784931
• Report Number: 1721279-2020-00219
• Device Sequence Number: 2909410
• Product Code: MFA
• UDI-Device Identifier: 00813132020316
• UDI-Public: (01)00813132020316(17)210513(10)FKK19E09A
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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): 10/06/2020

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: 05/13/2021
• Device Model Number: 500-013
• Device Catalogue Number: 500-013
• Device Lot Number: FKK19E09A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2020
• 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: SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS TIGHTRAIL SUB-C DILATOR SHEATH; ST. JUDE MEDICAL 7122Q RV ICD LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR