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

Model Number 518-067

Device Problems Difficult to Remove (1528); Material Distortion (2977)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 06/05/2017

Event Type  Injury  

Manufacturer Narrative

Patient weight is unavailable from the facility.(b)(4).

Event Description

It was reported that during a lead extraction procedure to remove 3 leads, the patient blood pressure dropped which required intervention to correct.Reportedly, the first (screwing lead) was removed without incident.The remaining two (tinned) leads were prepped with lld devices.A tightrail device was used to advance down the first lead, but progress stalled.At this point the patient's blood pressure dropped rapidly and the physician attempted to removed the tightrail.However, upon removal of the tightrail, the lld device also withdrew from the lead, and was noted to be "completely distorted".After administration of nor-epinephrine and the release of traction, the blood pressure corrected and the procedure continued.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 6677101
• MDR Text Key: 78699760
• Report Number: 1721279-2017-00122
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K043401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/05/2017

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: Physician
• Device Expiration Date: 04/19/2019
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: FLK17D17A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2017
• Initial Date FDA Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2017
• 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: SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR