MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER

Model Number 423-050

Device Problem Insufficient Information (3190)

Patient Problem Embolism (1829)

Event Date 11/19/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Vascular intervention case to treat a cto of the sfa.The physician successfully treated the vessel using the turbo-power laser catheter.Upon removal of the spider filter wire micro emboli were noted.It was the opinion of the physician that this is an inherent risk of the procedure.The physician made no allegations of deficiency against this device.

Manufacturer Narrative

Device evaluation: an inspection of the device tip found 3 fibers that may have had very small chips; however these chips would have been very small in size and would not resulted in enough material to create the emboli visualized in this complaint.The device was in near excellent condition.The physician in this case reported that this adverse event was most likely due to patient lesion condition and not that of the device used.

• Brand Name: SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER
• Type of Device: TURBO-POWER
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: sondra chandler ; 9965 federal dr; colorado springs, CO 80921 ; 719447-253
• MDR Report Key: 5287774
• MDR Text Key: 33243690
• Report Number: 1721279-2015-00183
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152181
• 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,Followup,Followup
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/28/2016
• Device Model Number: 423-050
• Device Catalogue Number: 423-050
• Device Lot Number: CMP15J24A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/24/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 88