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 Problem Laceration(s) (1946)

Event Date 04/29/2022

Event Type  Injury  

Manufacturer Narrative

For this event, section a captures user information.User date of birth/age unk.User weight unk.The device was discarded, thus no investigation could be completed.Because it is uncertain how the laceration to the user's finger occurred, a cause for this event could not be established.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead due to non function.A right atrial (ra) lead was present within the patient, but was not targeted for extraction.A spectranetics lead locking device (lld) was inserted into the rv lead to provide traction.The physician began by using a spectranetics 14f glidelight laser sheath and a spectranetics visisheath dilator sheath but was unable to progress through the lead on lead binding in the brachiocephalic region.The physician then upsized to a 16f glidelight an visisheath.Slight progress was made, but could not get through the lead on lead binding.He then switched to a spectranetics 13f tightrail rotating dilator sheath with its outer sheath.Progress was made to the superior vena cava (svc) and into the right atrium.The lead's coil began to snowplow (bunch up).The outer sheath could be advanced, but not the inner tightrail, when the lead released.The physician wanted to retain access through the outer sheath for re-implantation so he attempted to pull the tightrail out of the outer sheath, but it was stuck on the lead (mdr #1721279-2022-00098).He then tried to pull the rv lead out, and while he was applying significant traction, his hand slipped down the lld and cut through his gloves and cut his finger.The physician had utilized a kelly forcep applied to the lld to assist with gripping the lld, and it was uncertain if his hand slipped off the forcep or just down the lld.There was a large amount of bleeding and the physician went to the emergency department (ed) for treatment; the injury was able to be glued together (no sutures were required).Another physician finished the procedure by wiggling the tightrail's outer sheath back and forth first, and then using a wire, he was able to remove the rv lead, the tightrail and its outer sheath all at the same time.The lld was intact the entire time and did not break or fracture.The procedure was completed with no reported patient harm.This report captures the laceration to the physician's finger while pulling on the lld, requiring intervention.

• 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): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 14362785
• MDR Text Key: 291474567
• Report Number: 1721279-2022-00097
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)240324(10)FLP22C15B
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2024
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP22C15B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• 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: MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 6935M RV ICD LEAD; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS VISISHEATH DILATOR SHEATHS; WIRE MANUFACTURER/SIZE UNK
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Hispanic