MAUDE Adverse Event Report: SPECTRANETICS STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON; DCB PTA CATHETER

Model Number AB35SX050120135

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

The patient's dob or age at time of event, sex, and weight are unknown.This information was not available from the facility.The compliance card did not match the size printed on the hub, pouch, and carton.However, the balloon size matched the hub, pouch, and carton.Recurrence of the labeling discrepancy could result in under treatment of the lesion.No patient injury reported.Patient information regarding relevant tests/laboratory data, or medical history is unknown.This information was not available from the facility.The stellarex device and compliance card were returned for evaluation.The balloon size (5 mm x 120 mm) printed on the hub matched the labeling on the carton, foil pouch, and inner pouch.However, the compliance card indicated a 6 mm balloon od and did not match the size of the device and packaging material.This did not result in patient injury.

Event Description

The balloon compliance chart in the sterile pack had a different size balloon.However, the procedure was completed successfully with the same device.No patient injury reported.

• Brand Name: STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
• Type of Device: DCB PTA CATHETER
• Manufacturer (Section D): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• Manufacturer (Section G): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• Manufacturer Contact: ana tan ; 5055 brandin court; fremont, CA 94538 ; 510933-798
• MDR Report Key: 7698120
• MDR Text Key: 114701136
• Report Number: 3009784280-2018-00078
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00813132023225
• UDI-Public: 00813132023225
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160049
• 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: 01/01/2005,06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2019
• Device Model Number: AB35SX050120135
• Device Catalogue Number: AB35SX050120135
• Device Lot Number: FHS17K18A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 01/14/2005
• Initial Date FDA Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other