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

Model Number	AB35SX050120135
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: DCB PTA CATHETER
• Manufacturer (Section D): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• MDR Report Key: 7698120
• Report Number: 3009784280-2018-00078
• Device Sequence Number: 1329904
• Product Code: ONU
• UDI-Device Identifier: 00813132023225
• UDI-Public: 00813132023225
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P160049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2018
• Report Date (Section F): 01/01/2005

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
• Operator of Device: 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
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005