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 08/09/2021

Event Type  Injury  

Manufacturer Narrative

Patient's weight unk.Portion of device remained in patient's body, thus no investigation could be completed.

Event Description

A lead extraction procedure commenced to extract a right ventricular (rv) icd lead due to non-function.The lead was prepped with a spectranetics lead locking device (lld) to maintain traction during the procedure.The physician then used a spectranetics 14f glidelight laser sheath along with a spectranetics medium visisheath dilator sheath.He proceeded down into the subclavian vein and into the left innominate vein.As the glidelight device reached the superior vena cava (svc)/innominate junction, the patient's blood pressure dropped.A hemothorax was noticed on imaging and a rescue balloon was deployed immediately.The cardiothoracic (ct) surgeon was called in and a sternotomy was performed.Two svc tears approximately 4-5 mm long were discovered and were successfully repaired (reference mdr #1721279-2021-00160).The physician attempted to unlock the lld from the rv lead and was unsuccessful; the rv lead, along with the lld, were cut and capped and left 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.

• 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: 12368704
• MDR Text Key: 268212773
• Report Number: 1721279-2021-00162
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)230430(10)FLP21D30A
• 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: 08/09/2021

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: 04/30/2023
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP21D30A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• 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): Other
• Patient Age: 55 YR