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

Model Number 518-062

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

Patient Problems Great Vessel Perforation (2152); Iatrogenic Source (2498); Atrial Perforation (2511)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

Patient's weight unavailable.

Event Description

A lead extraction procedure commenced to remove 3 leads (2 right atrial (ra) and 1 right ventricular (rv)).Spectranetics lead locking devices (lld''s) were inserted into each lead to provide traction to aid in lead removal.The physician had removed both ra leads successfully using a spectranetics 13f tightrail rotating dilator sheath.While removing the last lead (rv), the tightrail was unable to get over the lead due to the lead ''snowplowing''.The lead had a calcified knot on it.While trying to free the lead using traction with the lld, the patient's blood pressure dropped as soon as the lead had freed itself.The surgeon was in the room and rescue efforts began immediately.An effusion was noted on echocardiography.A sternotomy was performed and a 1 cm flap (tear) was discovered at the inferior vena cava (ivc)/right atrial (ra) junction.The tear was repaired successfully and the patient survived the procedure.There was no alleged malfunction of any spectranetics devices in use.Physician believes the tear was due to traction and the calcification on the lead.

• 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: 11020621
• MDR Text Key: 222001868
• Report Number: 1721279-2020-00256
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)220901(10)FLP20H28A
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K142116
• 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: 11/25/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP20H28A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2020
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 43 YR