MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION TIGHTRAIL ROTATING DILATOR SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	545-513
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	04/27/2023
Type of Reportable Event	Death
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) and a right atrial (ra) lead.A spectranetics lead locking device (lld) was used in the rv lead to provide traction.A spectranetics 14f glidelight laser sheath was used to attempt removal of the rv lead, but progress stalled in the subclavian.A spectranetics 11f tightrail rotating dilator sheath was used next, then upsized to a 13f tightrail due to the superior vena cava (svc) being very narrow and heavily calcified.The physician worked for a significant amount of time using the 13f tightrail to free the rv lead, and while in use, a piece of calcium pulled off, from the wall of the svc.It was understood that the calcium remained attached to the rv lead and did not embolize; however, it created an svc perforation where the calcium detached.Rescue efforts began immediately, including rescue balloon, bypass, and sternotomy.The svc was found to be severely calcified, with thin vessel wall.Unfortunately, the patient did not survive.The physician speculated that the rv lead many have externalized in the svc and the tightrail just followed the lead.It is unk if the ra lead was removed.This report captures the 13f tightrail in use when the perforation occurred, requiring intervention but resulting in death.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
Patient's date of birth unk.Patient's weight unk.Patient's ethnicity/race unk.Relevant tests/laboratory data unk.Device lot number, expiration date.Partial udi populated.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.Great vessel perforation and death are known risks of complication with use of the tightrail device.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Additional Manufacturer Narrative
A2): patient''s date of birth obtained; age corrected to 68 (from 60, listed on initial mdr).A4): patient''s weight obtained a5a./5b.): patient''s ethnicity/race obtained d10): manufacturer/model of rv and ra leads obtained; lv lead information obtained (not listed in initial mdr).H6): all codes remain applicable as populated in the initial mdr.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• Brand Name: TIGHTRAIL ROTATING DILATOR SHEATH
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 16988237
• Report Number: 1721279-2023-00082
• Device Sequence Number: 6932079
• Product Code: DRE
• UDI-Device Identifier: 00813132020897
• UDI-Public: 00813132020897
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

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: 545-513
• Device Catalogue Number: 545-513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC 4269 RA PACING LEAD; BOSTON SCIENTIFIC 4269 RV PACING LEAD; MEDTRONIC 4196 LV LEAD; RA LEAD MANUFATURER/MODEL UNK; RV LEAD MANUFACTURER/MODEL UNK; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Death
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White