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

Model Number 518-019

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2022

Event Type  Injury  

Manufacturer Narrative

The device was discarded, thus no investigation could be completed.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to bactermia and cied system/pocket infection.Prior to the procedure, an angiodynamics alphavac mechanical thrombectomy system was used, removing significantly more soft material (clots) than vegetation, present within the patient.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The physician attempted removal of the ra lead first.A spectranetics 13f tightrail sub-c rotating dilator sheath was being used within the innominate vein when the ra lead began to break.The lead insulation and the entire lld came out of the ra lead leaving only the lead filar remaining, requiring use of a cook medical bulldog lead extender to provide traction to the lead remnant.The physician then used a spectranetics 13f tightrail rotating dilator sheath which advanced farther to the svc but then the filar broke.The physician was able to extract the rv lead successfully.Then, the physician attempted ra lead remnant removal from a femoral access using a cook medical 16f outer sheath and a cook medical needle''s eye snare.The ra lead remnant was lodged in the lower svc.After approximately one hour of the outer sheath and the needle''s eye snare being used within the lower svc and ra regions, an effusion was noted.The physician was able to grab the lead remnant briefly and the ra lead tip was freed, hanging down in the ra.The effusion became larger.As the effusion grew, the patient's blood pressure dropped.Snaring attempt ceased and a pericardiocentesis was performed.On the first attempt, the pericardiocentesis drain was misplaced.A second drain was properly placed and patient began to stabilize.However, the patient's blood pressure dropped again and a rescue balloon was used, with the patient's blood pressure responding.After a while, however (approximate time unk), the patient's blood pressure flat lined.A significant amount of clots were noted by the physicians as they viewed the echocardiography after rescue balloon inflation.The physicians could not determine an exact injury location, since a sternotomy was not performed.A code was called, cpr began and the rescue balloon was deflated.The patient's blood was anticoagulated and the patient stabilized with 3 units of blood given.The effusion had resolved.The ra lead remnant was then snared from a femoral approach using a merit medical 7f en snare endovascular snare.The patient was sent to icu with the pericardiocentesis drain in place, and survived the procedure.This report captures the lld providing traction within the ra lead when the ra first began to break, requiring intervention for removal of the ra lead remnant.There was no alleged malfunction of any spectranetics devices in use during the procedure.Although a patient injury occurred, all spectranetics devices had been removed prior to snaring attempts, and concomitant manufacturers'' devices were in use when the effusion was detected.

Manufacturer Narrative

B4): the "date of this report" field was inadvertently left blank in the initial mdr that was submitted on 01 june 2022.

• 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 (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 14569016
• MDR Text Key: 293115662
• Report Number: 1721279-2022-00101
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: (01)00813132023010(17)231110(10)FLC21L08A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2023
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC21L08A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• 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: 6F GOOSENECK SNARE MANUFACTURER UNK; BOSTON SCIENTIFIC 7740 RA PACING LEAD; BOSTON SCIENTIFIC 7741 RV PACING LEAD; COOK MEDICAL 16F CURVED OUTER SHEATH; COOK MEDICAL NEEDLE'S EYE SNARE; DEFLECTABLE EP CATHETER MANUFACTURER UNK; MERIT MEDICAL 7F EN SNARE ENDOVASCULAR SNARE; SPECTRANETICS LEAD LOCKING DEVICE IN RV LEAD; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; SPECTRANETICS TIGHTRAIL SUB-C DILATOR SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White