MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER

Model Number 420-159

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation: during the evaluation of the device, the band on the distal tip was absent.Per the information provided by the facility, the band was not retrieved from the patient.It cannot be determined at this time what led to this failure mode.

Event Description

Procedure was an isr (in stent restenosis) within the sfa (superficial femoral artery).The marker band reportedly came off of the fiber upon pulling back after the first pass through the lesion.The marker band reportedly jumped forward as the catheter was being retracted.The procedure was significantly delayed due to multiple attempts to retrieve the marker.The marker tip migrated to the posterior tibial artery which was already occluded according to the angiogram performed by the physician, and the marker band remained in the patient.The patient survived event.

• Brand Name: SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER
• Type of Device: TURBO ELITE
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; n/a; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; n/a; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 6441292
• MDR Text Key: 71100876
• Report Number: 1721279-2017-00056
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071227
• 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
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/22/2018
• Device Model Number: 420-159
• Device Lot Number: FBH16L22A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2016
• 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 ANGIOSCULPT BALLOON CATHETER; SPECTRANETICS CVX-300 EXCIMER LASER; SPECTRANETICS QUICK-ACCESS NEEDLE HOLDER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention