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

Model Number	560-013
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's weight unk.The device was discarded, thus no investigation could be completed.
Event or Problem Description
A lead extraction procedure commenced to remove three leads: a right atrial (ra), an active right ventricular (rv) and a capped rv lead due to the need for an mri.Spectranetics lead locking devices were inserted into each lead to provide traction for the leads.The physician began by using a spectranetics 14f glidelight laser sheath and a spectranetics 33 cm visisheath dilator sheath to attempt to remove the active rv lead.He encountered stalled progression as a result of severe calcification and lead on lead binding, and chose to change to a spectranetics 13f tightrail sub-c rotating dilator sheath to clear a pathway to the superior vena cava (svc).He was successful with navigating through the clavicular region although there appeared to be some ''snowplowing'' (where the lead jacket bunches up on itself) on the adjacent leads.The tightrail sub-c device was then deployed on the adjacent capped rv lead.This resulted in the tightrail sub-c severing the capped rv lead.He then switched back to the 14f glidelight device on the active rv lead and experienced more stalled progression.He upsized to a 16f glidelight device, and was successful in removing the active rv lead.However, a sizeable amount of fibrotic tissue was adhered to the helix (distal tip) of the lead.The patient's blood pressure dropped.Rescue efforts began immediately, including rescue balloon and the chest was opened using bovie cautery.The physician was able to visually identify a rv perforation and a sternotomy was performed (mdr 1721279-2021-00222).The perforation was successfully repaired, all leads were successfully removed and re-implants of both the ra and rv leads were successful.The patient was transferred to the cardiovascular icu for recovery, and survived the procedure.This report captures the tightrail sub-c device which severed the capped rv lead, requiring intervention.There was no alleged malfunction of the tightrail sub-c device.Although an adverse event occurred as well during the procedure, it was unrelated to the tightrail sub-c device which severed the capped rv lead.

• Brand Name: SPECTRANETICS 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): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 12824406
• Report Number: 1721279-2021-00223
• Device Sequence Number: 1520989
• Product Code: DRE
• UDI-Device Identifier: 00813132022808
• UDI-Public: (01)00813132022808(17)230928(10)FRQ21J28A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161333
• 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
• Report Date (Section B): 10/26/2021

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: 09/28/2023
• Device Model Number: 560-013
• Device Catalogue Number: 560-013
• Device Lot Number: FRQ21J28A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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 4470 RA PACING LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES; ST. JUDE MEDICAL 1580 ACTIVE RV ICD LEAD; ST. JUDE MEDICAL 1580 CAPPED RV ICD LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White