MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ABLATION CATHETER; 2.5 TURBO ELITE

Model Number 425-135-02

Device Problem Obstruction of Flow (2423)

Patient Problem Occlusion (1984)

Event Date 03/10/2015

Event Type  Injury  

Event Description

This was a peripheral vascular intervention to treat in-stent re-stenosis (isr) in the sfa.A spider protection device was placed and a 2.5 turbo elite laser sheath was used to treat the long sfa occlusion/isr (35 cm).Two passes were made with the laser sheath.The occlusion was also treated with three drug-coated balloons (dcbs) and pre-dilated with a plain balloon.It was noted during the case that "widespread" embolization occurred.The spider protection device caught the emboli and the patient experienced no ill effects from the procedure.The patient was discharged per operative plan.

Manufacturer Narrative

Placeholder.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ABLATION CATHETER
• Type of Device: 2.5 TURBO ELITE
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION
• Manufacturer Contact: jessica hearn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 4645929
• MDR Text Key: 18627381
• Report Number: 1721279-2015-00050
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 425-135-02
• Device Catalogue Number: 425-135-02
• Device Lot Number: UNKNOWN
• Other Device ID Number: PARTIAL: M204425135020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 CVX-300 EXCIMER LASER SYSTEM; MEDTRONIC PACIFIC PTA CATHETER; BARD LUTONIX DRUG COATED BALLOON X3; EV3 SPIDERFX EMBOLIC PROTECTION DEVICE
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 102