MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number	518-067
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/14/2021
Type of Reportable Event	Serious Injury
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 the rv lead delivering inappropriate shocks.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The physician began the extraction attempt of the rv lead using a spectranetics 14f glidelight laser sheath, with progress stalling at the superior vena cava (svc)/innominate junction with obvious lead interaction with the ra lead.The physician then switched to the ra lead, progress stalling in the same area.The physician upsized to a 16f glidelight device and the extraction of the ra lead was successful shortly afterward.After approximately 2 minutes post extraction, the patient's blood pressure dropped.Rescue efforts began immediately, including rescue balloon, administration of blood products, and sternotomy.The surgical team worked for 13 minutes to stabilize the patient.No obvious tear was noted in either the svc or in the heart, but large clotting was noted, and the tear was presumed closed.After consultation with colleagues, it was decided to attempt removal of the rv lead, since the patient's chest was open and the team had full access.The 16f glidelight device was used over the rv lead with minimal lasing before another immediate blood pressure drop occurred.The patient was placed on bypass and further blood products were administered.A high svc perforation was noted by surgeons (mdr #1721279-2022-00001).The repair to the svc perforation was successful and the physicians decided to leave the rv lead within the patient.The physician attempted to unlock the lld from the rv lead, but the lead/lld had already been stretched with traction and could not be unlocked successfully.The rv lead and lld within it were cut and capped and remained in the patient.The patient survived the procedure.This report captures the lld which would not unlock and was cut and capped within the rv lead and remained in the patient.
Additional Manufacturer Narrative
The device was discarded, thus no investigation could be completed.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Common Device Name: STYLET, CATHETER
• 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: 13212211
• Report Number: 1721279-2022-00002
• Device Sequence Number: 1534028
• Product Code: DRB
• UDI-Device Identifier: 00813132023065
• UDI-Public: (01)00813132023065(17)230625(10)FLK21F24A
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142116
• 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): 12/14/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/25/2023
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: FLK21F24A
• 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: 12/14/2021
• Initial Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2021
• 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: RA PACING LEAD MANUFACTURER AND MODEL UNK; RV ICD LEAD MANUFACTURER AND MODEL UNK; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE IN RA LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White