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

Model Number 518-062

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/10/2021

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to non function.A spectranetics lead locking devices (llds) were inserted into both the ra and rv leads to provide traction to aid in the extractions.Using a spectranetics tightrail rotating dilator sheath, the physician first removed the ra lead.However, a large amount of tissue was observed on the tip of the ra when removed.A pericardial effusion was detected and rescue efforts began immediately, including rescue balloon, administration of blood products, cpr, bypass and sternotomy.A right atrial perforation was discovered and the area was successfully repaired (reference mdr #1721279-2021-00165).The physician chose not to remove the rv lead and attempted to unlock the lld from the rv lead in order to remove it, but was unsuccessful.The lld, along with the rv lead, was cut and capped and remained in the patient.The patient survived the procedure.This report captures the lld which was cut and capped within the rv lead and remained in the patient.

Manufacturer Narrative

Portion of the device remained in patient, thus no investigation could be completed.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 12396895
• MDR Text Key: 280547149
• Report Number: 1721279-2021-00166
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023076
• UDI-Public: (01)00813132023076(17)230325(10)FLP21C24A
• Combination Product (y/n): Y
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 08/10/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2023
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP21C24A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPECTRANETICS LEAD LOCKING DEVICE IN RA LEAD; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; ST. JUDE MEDICAL 1342T RA PACING LEAD; ST. JUDE MEDICAL 1346T RV ICD LEAD
• Patient Outcome(s): Other
• Patient Age: 51 YR