MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS GLIDELIGHT LASER SHEATH; 16 FR. GLIDELIGHT

Model Number 500-303

Device Problem Physical Resistance (2578)

Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930)

Event Date 08/28/2014

Event Type  Injury  

Event Description

This was a lead removal case performed in the or to remove a single chamber icd and a riata 1591 (implanted (b)(6) 2006) due to a pocket infection.Physician began with a 14fr glidelight and a pre-loaded visisheath (m-33).The lead was prepped with an lld-ez and a cook one-tie.With the 14fr glidelight, physician progressed until midpoint of the svc coil where significant resistance was met.Physician was able to advance visisheath past binding spot, but not the 14fr glidelight.The physician elected to upsize to a 16fr glidelight, but noticed some externalization of the riata cables outside of the venous access point.He took off the one-tie and was able to pull the cables back in.He then used a cook bulldog on the cables and loaded them through the 16fr glidelight catheter.No outer sheath was used this time.Physician was then able to clear the midpoint of the svc coil, using a minimal amount of quick, forward advancement at the tough adhesion spot.The blood pressure remained stable as the physician lasered past the turn in the ra/svc juncture and then down the lateral svc wall.Physician progressed slowly, ensuring the bevel orientation was away from the lateral wall.As the 16fr glidelight was entering the ra, the blood pressure starting rapidly dropping.The laser was shut off and cleared away and the surgical response team took over for the invasive rescue.A sternotomy was performed, the leads removed, and the patient survived the rescue.

• Brand Name: SPECTRANETICS GLIDELIGHT LASER SHEATH
• Type of Device: 16 FR. GLIDELIGHT
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: linda todd ; 9965 federal drive; colorado springs, CO 80921 ; 7194472567
• MDR Report Key: 4071657
• MDR Text Key: 21731232
• Report Number: 1721279-2014-00146
• Device Sequence Number: 1
• Product Code: MFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960042
• 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: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/17/2015
• Device Model Number: 500-303
• Device Catalogue Number: 500-303
• Device Lot Number: FGC13M17A
• Other Device ID Number: M20450030308011215FGC13M17A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2013
• 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: COOK ONE-TIE; LLD-EZ; SJM RIATA 1591 LEAD; VISISHEATH, SIZE M (MEDIUM); 14F GLIDELIGHT; CVX-300 EXCIMER LASER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 34 YR