MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS TURBO-TANDEM LASER GUIDE CATHETER WITH LASER ATHERECTOMY CATHETER; TURBO TANDEM

Model Number 472-110

Device Problems Thermal Decomposition of Device (1071); Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation results: during product evaluation it was noted that the distal portion of the ramp was melted and the distal marker band was missing.The ramp appeared to be damaged due to laser energy; the device damage is consistant with laser activaton prior to the distal tip properly being placed on top of the ramp.

Event Description

Vascular intervention case to treat a cto in the sfa.At the midpoint of the sfa the physician began to feel resistance.The physician attempted to remove the turbo tandem and met resistance.Once the turbo tandem was removed the tip was noted to be burned.The physician completed the case using pta.No injury was caused to the patient and the patient was discharged as planned.

• Brand Name: SPECTRANETICS TURBO-TANDEM LASER GUIDE CATHETER WITH LASER ATHERECTOMY CATHETER
• Type of Device: TURBO TANDEM
• 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: 5223608
• MDR Text Key: 31462608
• Report Number: 1721279-2015-00177
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K094036
• 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: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/03/2016
• Device Model Number: 472-110
• Device Catalogue Number: 472-110
• Device Lot Number: FBX14J03A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2014
• 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): Required Intervention