MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD

Model Number UNAVAILABLE

Device Problems Break (1069); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

Patient weight was unavailable.Device lot number and expiration date are not available from the facility.The device was discarded by the user.Device manufacture date is dependent on the device lot number, thus is unavailable.The device was discarded.There is no allegation of a malfunction.Therefore, no device evaluation will be performed.

Event Description

A philips representative reported that a cardiac lead management procedure commenced on (b)(6) 2019 to remove 3 leads due to cardiac implantable electronic device (cied) pocket infection.The patient had two (b)(6) year old leads (1 right ventricular and 1 right atrial), and one (b)(6) year old lead (right ventricular medtronic pacing lead 5092).Two of the leads could not be removed through extraction.A spectranetics lead locking device (lld) #2 was being utilized to put traction on the (b)(6) year old rv lead when the lead with the lld snapped and broke off, so only the proximal part was removed.The distal part of the lld remained in the lead.The surgeons performed open heart surgery the next day on (b)(6) 2019 and all the leads, along with the lld were removed.The patient later expired on (b)(6) 2019 due to complications with the open heart procedure.

Manufacturer Narrative

Lead information and which lead snapped during the case was incorrectly reported at the time of the initial mdr submission.Corrected information was reported by the rep who was at the case on 17 july 2019.Additional information re: lead extraction and a lead/lld cut/cap was also provided and populated in this section.D1, d2, d4): suspect device remains a lead locking device; however no model, lot, or udi information is available for this lld which snapped while attempting extraction of the ra lead.

Event Description

In the previous mdr report, it was reported that the 20 year old rv lead(5092) was being removed when the lead snapped, along with the lld.This has been reported to not be the case.In subsequent conversations on (b)(6) 2019 with the rep who was present in the case, lead extraction information was clarified.He reported that lead 5092 rv lead (228 mo implant) was removed during the lead extraction procedure without issue.It was reported that the 4524 ra lead (324 mo implant) was the one in which the lead snapped along with the lld which was in the lead.The 4024 rv lead (324 mo implant) would not release despite attempts to do so.The 4524 ra lead along with the lld was capped for planned removal the next day; the 4024 rv lead along with an lld present within the lead, was cut/capped as well, and both of these leads were removed in an open heart procedure that occurred on (b)(6) 2019.Also clarified that the 4524 ra lead (and the lld) snapped near the end of the innominate vein, near the svc.The patient''s subsequent reported death on (b)(6) 2019 was not related to the lead/lld snapping.

Manufacturer Narrative

Correcting to adverse event and product problem, as lld snapped.Device problem code now provided.Placeholder.

Manufacturer Narrative

B2): outcomes corrected to "other" since lld snapped and was cut and capped, instead of "death" (captured in the initial mdr).G3): manufacturer became aware of the need for supplemental correction mdr on 03 aug 2021.H1): type of reportable event corrected to "serious injury".H6): heic code 1802 not applicable for this report.Device code 2976 corrected to 1069 (lld snapped).Postmarket surveillance performed a record review and discovered that three mdr''s (1721279-2019-00111, 1721279-2019-00127, and 1721279-2019-00128) were submitted for "death" for the same patient.This duplicated the patient''s death, which trended more deaths than actually occurred.This supplemental mdr is being submitted to change "death" to "injury", accurately reflecting the event and avoiding "death" duplication.Mdr #1721279-2019-00127 will remain unchanged.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 8736448
• MDR Text Key: 149254460
• Report Number: 1721279-2019-00111
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023027
• UDI-Public: 00813132023027
• Combination Product (y/n): Y
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/01/2005,06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• 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: 518-022
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDTRONIC 4524 PACING LEAD; MEDTRONIC 5092 PACING LEAD; MEDTRONIC PACING 4024 LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH; MEDTRONIC 4524 PACING LEAD; MEDTRONIC 5092 PACING LEAD; MEDTRONIC PACING 4024 LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Death; Other; Required Intervention
• Patient Age: 39 YR