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

Model Number	AB35SX060040135
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inflation, the balloon ruptured below rbp.No patient injury reported, this mdr is being reported per fda request.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.The stellarex device was discarded by the facility, thus no returned product investigation was performed.Per the ifu, balloon rupture is listed as a potential complication of the peripheral balloon.
Event or Problem Description
From a contralateral femoral approach, the stellarex device was used to treat a pre-dilated right mid sfa.During inflation below nominal pressure, the balloon ruptured.The procedure was completed with a competitor 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: 11345001
• Report Number: 3009784280-2021-00011
• Device Sequence Number: 20073672
• Product Code: ONU
• UDI-Device Identifier: 00813132023232
• UDI-Public: 00813132023232
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2021

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: 10/15/2021
• Device Model Number: AB35SX060040135
• Device Catalogue Number: AB35SX060040135
• Device Lot Number: FHT19J25A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2021
• 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
• Patient Age: 76 YR
• Patient Weight: 113