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

Model Number 518-039

Device Problem Break (1069)

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

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

Patient date of birth and age unavailable.Patient weight unavailable.(b)(4).Device evaluation: the device was evaluated on 24 mar 2021 by a cross functional team.Two portions of the lld were returned to the manufacturer, comprising the lld in its entirety along with a portion of the lead present on the distal portion of the broken lld.The lld was fractured just distal of the wave feature, located on the mandrel of the device.The fractured area appears to have been stretched and then snapped.The lead, present around the distal portion of the broken lld, was cut and removed in order to fully evaluate this segment.In the area of fractured on the proximal portion of the broken lld, it also appears to have been stretched and snapped.The cause of why the lld broke in this area could not be determined; however, there was no indication of a design or production process related failure.The pulling force applied to the device exceeded the mandrel's strength.This failure has been determined to be use related, as traction was applied to the lld that exceeded the mandrel's strength, causing the lld to fracture.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead due to non function.A spectranetics lead locking device was inserted into the rv lead to provide traction to aid in the lead's extraction.It was reported that during the procedure, the lld broke inside the lead with use of traction.The physician then attempted to extract the lead by using just suture, tied to the insulation of the lead, then used a cook medical bulldog device to attempt the extraction.However, the lead tip would still not release from the rv.The physician placed a new lead within the patient, and chose to cut and cap the rv lead and abandoned it within the patient's body.Both portions of the lld were able to be removed, so the lld was removed in its entirety from the lead and from the patient's body.The procedure was completed with no reported patient harm.Due to the lld breaking within the lead, this report is being submitted due to the potential for complication with recurrence.The lld portions, comprising the entire lld, were returned to the manufacturer for evaluation.

Manufacturer Narrative

B1): has been corrected to "product problem".H1): has been corrected to "malfunction".There was no reported injury to the patient; these fields were incorrectly populated on the initial mdr.Corrections to b1 and h1 now made to accurately reflect the event.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 11604414
• MDR Text Key: 243529223
• Report Number: 1721279-2021-00051
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023058
• UDI-Public: (01)00813132023058(17)210816(10)FLJ19H15A
• Combination Product (y/n): Y
• PMA/PMN Number: K043401
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2021
• Device Model Number: 518-039
• Device Catalogue Number: 518-039
• Device Lot Number: FLJ19H15A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK MEDICAL BULLDOG LEAD EXTENDER; MEDTRONIC 4076 RV PACING LEAD; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; SUTURE MANUFACTURER UNKNOWN; COOK MEDICAL BULLDOG LEAD EXTENDER; MEDTRONIC 4076 RV PACING LEAD; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; SUTURE MANUFACTURER UNKNOWN
• Patient Outcome(s): Other