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

Model Number	545-511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Great Vessel Perforation (2152); Pericardial Effusion (3271)
Date of Event	04/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental mdr to follow upon availability to enter component code (b)(4).
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to non function and occlusion.A second rv lead and a left ventricular (lv) lead were present in the patient but were not targeted for extraction.To provide traction to aid in lead removal, the physician chose to use cook liberator locking stylets in the leads.The physician then chose a spectranetics 14f glidelight laser sheath to begin the procedure, attempting extraction of the ra lead first.During use of the glidelight device, the patient's blood pressure dropped briefly but quickly returned to normal after the team paused with the extraction.At that time, no effusion was detected using transesophageal echocardiography (tee).The extraction then continued with use of the glidelight device, when stalled progress was encountered in the superior vena cava (svc)/ra junction.The physician then switched tools to a spectranetics 11f tightrail rotating dilator sheath and continued with the extraction.Progress continued to approximately 2cm from the tip of the ra lead.At that time, the patient's blood pressure dropped again and an effusion was noted via tee.Rescue efforts began immediately, including rescue balloon, pericardiocentesis, sternotomy and bypass.An extensive tear, from the innominate through the svc was discovered.Repair to the area was successful; the ra lead was removed during the repair and a portion of the rv lead was removed as well, leaving the distal portion of the rv lead in the right ventricle.The patient survived the procedure.There was no alleged malfunction of any spectranetics device in use during the procedure.Although the glidelight device was present within the area of injury as well, an effusion was not detected until after use of the tightrail device.
Additional Manufacturer Narrative
H3): the device was discarded, thus an investigation could not be completed.H6): added codes: 4755, 4619, and 4621.

• 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
• MDR Report Key: 11778750
• Report Number: 1721279-2021-00081
• Device Sequence Number: 3998162
• Product Code: DRE
• UDI-Device Identifier: 00813132021641
• UDI-Public: (01)00813132021641(17)210718(10)FRK19G18A
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K150360
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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: 07/18/2021
• Device Model Number: 545-511
• Device Catalogue Number: 545-511
• Device Lot Number: FRK19G18A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/23/2021
• 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: COOK MEDICAL LIBERATOR LOCKING STYLETS; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; ST. JUDE MEDICAL 1056T LV LEAD; ST. JUDE MEDICAL 1488T RA PACING LEAD; ST. JUDE MEDICAL 1488T RV PACING LEAD; ST. JUDE MEDICAL 7001 RV ICD LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 149