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); Cardiac Perforation (2513)

Event Date 10/21/2021

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unk.The device was discarded, thus no investigation could be completed.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead due to recall.A spectranetics lead locking device (lld) was inserted into the rv lead to provide traction to the lead.The physician also used a spectranetics 16f glidelight laser sheath during the procedure.While the physician was lasing within the superior vena cava (svc)/innominate junction, the rv lead freed.The glidelight device and the lead were removed and the patient became hypotensive.An effusion was noted, and the cardiothoracic surgeon immediately entered the room.A sternotomy was performed and a small perforation in the innominate vein (see mdr #1721279-2021-00203) and a large perforation in the distal svc and ra junction were discovered.The physician noted that the glidelight device never made it down to the svc and ra junction, but that the lead must have been attached and when it pulled off the wall as traction was being applied, the perforation occurred.The repairs were successful and the patient survived the procedure.This report captures the lld providing traction to the rv lead when the svc and ra junction perforation occurred.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• 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): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 12741311
• MDR Text Key: 279922200
• Report Number: 1721279-2021-00202
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132020347
• UDI-Public: (01)00813132020347(17)230824(10)FGC21H17A
• 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: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2023
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP21G07A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 88