MAUDE Adverse Event Report: SPECTRANETICS STELLAREX 035; DCB PTA CATHETER

Model Number A35SX060060080

Device Problems Material Rupture (1546); Material Separation (1562)

Patient Problem Stenosis (2263)

Event Date 01/12/2022

Event Type  Injury  

Manufacturer Narrative

The patient's dob or age at time of event, weight, ethnicity, and race are unknown.This information was not available from the facility.Patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Foreign: (b)(6).The stellarex device has not been returned by the facility, thus no returned product investigation was performed.Per the ifu, balloon rupture and detachment of a component of the balloon and/or catheter system are listed as a potential complication of the peripheral balloon.

Event Description

The stellarex device was used in a severely calcified proximal popliteal artery.During inflation before reaching nominal pressure, the balloon burst.The balloon could not be pulled out over the short 6f lock and unable to be removed using a snare.The sheath was upsized in an attempt to remove the balloon, but was unsuccessful.A small part of the balloon remained in the arteria femoralis communis (afc) and caused a high-grade stenosis, thus surgical removal was required.The patient is reportedly doing well.This adverse event and product problem is being submitted due to the surgical intervention performed to remove the separated balloon.

Manufacturer Narrative

Block d9/g3: the angiosculpt device was returned for evaluation.Block h3: the stellarex 035 catheter was returned in three pieces.Both the distal shaft and balloon separated from the rest of the device and the inner shaft within the balloon was severely stretched.Visual inspection found a damaged distal tip and a longitudinal and radial tear on the proximal end of the balloon.Block h6: the cause of the radial balloon tear may be due to lesion morphology (severely calcified lesion).The cause of the device separation is likely due to some degree of force applied by the user in order to remove the device from the patient.

• Brand Name: STELLAREX 035
• Type of Device: DCB PTA CATHETER
• Manufacturer (Section D): SPECTRANETICS; 6655 wedgwood road north; suite 105; maple grove MN 55311
• Manufacturer (Section G): SPECTRANETICS; 6655 wedgwood road north; suite 105; maple grove MN 55311
• Manufacturer Contact: ana tan ; 6655 wedgwood road north; suite 105; maple grove, MN 55311
• MDR Report Key: 13387014
• MDR Text Key: 289204064
• Report Number: 3011416935-2022-00001
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P160049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: A35SX060060080
• Device Catalogue Number: A35SX060060080
• Device Lot Number: F7M20H14A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 01/28/2022
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2020
• 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: 6F INTRODUCER SHEATH MFG UNK; COOK: 0.035" BENTSON GUIDEWIRE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female