MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER

Model Number 420-159

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/24/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation: during the evaluation, the band was absent from the tip of the catheter.Per the information provided by the facility, the band was not retrieved.There was slight wrinkling seen at the distal tip and a prolapse was seen on the outer jacket.It cannot be determined at this time what led to this failure mode.

Event Description

Isr (in stent restenosis) procedure being performed in the right popliteal artery using a turbo elite device, due to 80% narrowing present in stent.After 1st pass through the lesion, physician pulled catheter back and discovered tip was off catheter.Physician attempted to snare tip without success; tip migrated down toward ankle and lodged in peroneal artery.Case completed by other means; patient survived procedure.

• Brand Name: SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER
• Type of Device: TURBO ELITE
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 6494834
• MDR Text Key: 72880631
• Report Number: 1721279-2017-00066
• 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: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/24/2019
• Device Model Number: 420-159
• Device Lot Number: FBH17B24A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2017
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention