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

Model Number 518-062

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

Patient weight is 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 suspect lld device was returned and evaluated on 11 september 2019 with a philips cross-functional team.During the evaluation it was confirmed there were two breaking points on the lld device, but they were slightly different from what the philips representative had reported.The most proximal breaking point, break point one, was located on the core mandrel just distal of the crimped hypotube of the proximal loop.The proximal end of the device, including the proximal loop and the crimped hypotube had not been returned for evaluation.The team measured from the proximal side of the wave form, to break point one or where the crimped hypotube would be located.The distance measured to be 20.75 inches.The specification for this length measurement is 22.25 +/ 0.5 inches.Since the 20.75 inches does not fall within that specification, it was determined the device broke on the core mandrel before the crimped hypotube.This means the crimped hypotube could not have been a factor for break point one.Upon evaluating break point one under the microscope, it was determined there was a slight indentation at the end of the break point.This indentation could be representative of a kink or damage before the lld device broke.The most distal break point, break point two, was located on the core mandrel 2 inches distal of the wave form and proximal to the braided mesh.The distal end of the device, including the majority of the working length and braided mesh, was not returned for evaluation.Looking at break point two under a microscope, it was determined the break point was at an angle.The angle of the break point could indicate a kink or damage to the device before the device broke.Both break points had some indication for kinking or damage.A kink or damage can lead to a weakened stress point on the device, which in turn could cause the kinked or damaged location to be more susceptible to failing when traction forces are applied to the device.The team was unable to determine the cause of the possible kink or damage to the device.

Event Description

A cardiac lead management procedure commenced to extract two pacing leads (one right ventricular and one right atrial) due to cardiac implantable electronic device (cied) pocket infection.A spectranetics lead locking device ez was utilized as the traction platform for lead extraction.The lld ez broke during use.The physician was able to successfully extract the lead and all pieces of the lld during the procedure.There was no harm to the patient.The philips representative attending the case did not observe any technique practices that would contribute.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: catherine eaton ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 9077077
• MDR Text Key: 158899694
• Report Number: 1721279-2019-00162
• Device Sequence Number: 1
• Product Code: DRB
• 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: 01/01/2005,08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: 346366 PACING LEAD; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; ZY44RJUSBV PACING LEAD
• Patient Outcome(s): Other
• Patient Age: 67 YR