MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS

Model Number	500-301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	02/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove four leads.Two leads were from a left access (right atrial (ra) lead (siello s) and a non functional right ventricular (rv) lead (linox smart s), and two were from a right access (ra lead (solia s) and rv lead (protego s), due to non function and a redundant lead.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The right sided ra (solia) lead was successfully removed using a cook medical 11f evolution shortie and cook medical evolution 11f rl devices.Attempting to remove the right sided rv (protego s) lead, the physician used the evolution 11f shortie, but met stalled progression, so switched devices to a spectranetics 12f glidelight laser sheath.The glidelight was advancing near the superior vena cava (svc)/ra junction, but met stalled progress again.He removed the glidelight device from the patient in order to change devices, but the patient''s blood pressure dropped rapidly.Rescue efforts began immediately, including rescue balloon, percutaneous cardiopulmonary support (pcps), sternotomy and bypass.A perforation in the svc was discovered (mdr #1721279-2022-00052).The repair to the perforation was successful.The physician did not attempt to remove the remaining three leads.He attempted to unlock each lld from the leads, but was unsuccessful.The left sided ra lead/lld (mdr #1721279-2022-00053), the left sided rv lead/lld (mdr #1721279-2022-00054) and the right sided rv lead/lld (mdr #1721279-2022-00055) were all cut, capped and remained in the patient.The patient survived the procedure.This report captures the 12f glidelight device in use when the svc perforation occurred, requiring intervention.There was no alleged malfunction of the glidelight device in use during the procedure.
Additional Manufacturer Narrative
Patient's date of birth, age unk.Patient's gender unk.Patient's weight unk.Relevant tests/laboratory data unk.Other relevant history unk.The device was discarded, thus no investigation could be completed.

• Brand Name: SPECTRANETICS 12F GLIDELIGHT LASER SHEATH
• Common Device Name: DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
• 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
• MDR Report Key: 13739049
• Report Number: 1721279-2022-00052
• Device Sequence Number: 17333821
• Product Code: MFA
• UDI-Device Identifier: 00813132020323
• UDI-Public: (01)00813132020323(17)230518(10)FGA21E04A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P960042 S070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2022

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: 05/18/2023
• Device Model Number: 500-301
• Device Catalogue Number: 500-301
• Device Lot Number: FGA21E04A
• 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: 02/18/2022
• Initial Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• 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: BIOTRONIK LINOX SMART S RV ICD LEAD; BIOTRONIK PROTEGO S RV ICD LEAD; BIOTRONIK SIELLO S RA PACING LEAD; BIOTRONIK SOLIA S RA PACING LEAD; COOK MEDICAL 11F EVOLUTION RL DILATOR SHEATH; COOK MEDICAL 11F EVOLUTION SHORTIE SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian