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

Model Number UNAVAILABLE

Device Problem Mechanical Problem (1384)

Patient Problems Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unavailable.Patient's weight unavailable.Device model number, lot number, expiration date and udi unavailable.510k number unavailable because model number unavailable.Device manufacture date unavailable because lot number unavailable.

Event Description

A lead extraction procedure commenced to remove two right ventricular (rv) leads (riata 1582 icd lead and a 1688tc pacing lead) due to non function/redundant lead.A right atrial (ra) lead was present within the patient but was not targeted for extraction.Spectranetics lead locking devices (lld's) were inserted into each of the rv leads to provide traction to aid in extraction.The physician chose a spectranetics 14f glidelight laser sheath and began the attempt at extracting the riata lead; progress stalled in the innominate region.The physician then switched to the 1688tc lead and stalled progress was met in the superior vena cava (svc).He then chose to use a spectranetics 11f tightrail rotating dilator sheath on the 1688tc and the lead was successfully extracted.A spectranetics 13f tightrail device was then opened and used on the riata.Binding to the ra lead and to the side wall was noted in the lower svc/right atrial (ra) junction but was overcome using manual dilation with the 13f tightrail device.3-5 minutes later, an effusion was noted on transesophageal echocardiography (tee).The effusion continued to grow in size.A pericardiocentesis was attempted but the patient's blood pressure continued to drop.Rescue efforts began immediately, including rescue balloon, cpr and sternotomy.A tear was discovered in the lower svc/ra junction and was successfully repaired (please reference mdr 1721279-2020-00249 which captures this injury occurring during use of the 13f tightrail device).The patient's blood pressure returned to normal levels; it was noted the patient did not go on cardiac bypass.The riata 1582 rv lead and the lld contained within the lead were cut and capped and remained within the patient's body.The patient survived the procedure.It was thought by the philips representative present in the procedure that the physician attempted to unlock the lld prior to cutting and capping it within the lead, but was unsuccessful.This complaint captures the lld which was present within the riata lead and was cut, capped and remained in the patient.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 10992153
• MDR Text Key: 220942760
• Report Number: 1721279-2020-00248
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNAVAILABLE
• Device Catalogue Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE; ST. JUDE MEDICAL 1688TC RA PACING LEAD; ST. JUDE MEDICAL 1688TC RV PACING LEAD; ST. JUDE MEDICAL RIATA 1582 RV ICD LEAD
• Patient Outcome(s): Other
• Patient Age: 54 YR