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

Model Number	AB35SX060060135
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's age at time of event or dob, gender, and weight are unknown.This information was not available from the facility.During inflation, the balloon ruptured.Recurrence of this malfunction could result in a prolonged intervention.No patient injury reported.Patient information regarding relevant tests/laboratory data or medical history are unknown.Per fda request, this mdr is being reported retrospectively.The stellarex device was returned for investigation.Visual inspection found no unusual characteristics of the device.During functional testing, the balloon was attempted to inflate to nominal pressure, but unable due to an occluded lumen.The device was examined under a microscope, and a pinhole tear was noted on the distal end of the balloon.Per the ifu, balloon rupture is listed as a potential complication of the peripheral balloon.
Event or Problem Description
During inflation in a calcified lesion, the stellarex balloon burst at 8 psi (5 atm).

• 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: 9513729
• Report Number: 3009784280-2019-00742
• Device Sequence Number: 11438816
• Product Code: ONU
• UDI-Device Identifier: 00813132024291
• UDI-Public: 00813132024291
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P160049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2019
• 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: 09/27/2020
• Device Model Number: AB35SX060060135
• Device Catalogue Number: AB35SX060060135
• Device Lot Number: FVY18J13A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• 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: 04/16/2019
• Initial Report FDA Received Date: 12/23/2019
• 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