MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SLS II LASER SHEATH

Model Number	500-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Iatrogenic Source (2498)
Date of Event	01/01/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient date of birth unavailable.Patient weight unavailable.However, patient's body mass index (bmi) is reported as 30.4.Device lot# and expiration date unavailable.Device manufacture date unavailable.Özkartal, tardu, et al.¿new onset of phrenic nerve palsy after laser-assisted transvenous lead extraction: a single-centre experience.¿ ep europace, 2018, doi:10.1093/europace/euy044.
Event or Problem Description
This event is documented as part of a literature review completed by clinical department at spectranetics (spnc).Spnc was made aware of this information on (b)(6) 2018.The february 2018 article from the european society of cardiology entitled, "new onset of phrenic nerve palsy after laser-assisted transvenous lead extraction: a single-centre experience", documented a new onset of phrenic nerve palsy (pnp) after laser-assisted transvenous lead extraction in five patients, confirmed by a newly elevated hemidiaphragm after extraction; all the patients who exhibited pnp were referred for lead extraction between january 2009 and september 2012, with actual procedure date unknown, so is populated as 1st of january, 2009.Patient had a right ventricular (rv) lead extracted using an sls device.After a broad diagnostic workup, including echocardiography and repeated reprogramming of the device, a chest x-ray revealed an ipsilateral elevation of the hemidiaphragm allowing the diagnosis of pnp.Patient had experienced atypical chest pain, diagnosed with pnp after two weeks.Symptoms improved gradually and disappeared within 3-6 months without necessity of any treatment.

• Brand Name: SLS II LASER SHEATH
• Common Device Name: SLS
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 7870049
• Report Number: 1721279-2018-00122
• Device Sequence Number: 1938961
• Product Code: MFA
• UDI-Device Identifier: 00813132020293
• UDI-Public: 00813132020293
• Combination Product (Y/N): Y
• Initial Reporter Country: SZ
• PMA/510(K) Number: P960042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2018
• 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?: 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: 08/16/2018
• Initial Report FDA Received Date: 09/12/2018
• 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: Other
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005