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

Model Number	AB35SX060120135
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2019
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 would not hold pressure.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 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
The balloon was pressurized to less than rbp, but would not hold pressure.A new stellarex device was used to complete the procedure.
Additional Manufacturer Narrative
Block a: include patient age, gender, and weight block d11: include guide wire and introducer sheath information h3 other text : placeholder.

• 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: 9528630
• Report Number: 3009784280-2019-00759
• Device Sequence Number: 14246777
• Product Code: ONU
• UDI-Device Identifier: 00813132023256
• UDI-Public: 00813132023256
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 05/13/2019
• 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: 12/15/2020
• Device Model Number: AB35SX060120135
• Device Catalogue Number: AB35SX060120135
• Device Lot Number: FHV18L05A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 12/29/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK: 6F ANSEL SHEATH.; CSI: 0.014" VIPERWIRE.; UNK MFG AND SIZE: GUIDE CATHETER.; UNK MFG AND SIZE: GUIDE WIRE.; UNK MFG AND SIZE: INTRODUCER SHEATH.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Weight: 97
• Date Report Sent to FDA: 01/01/2005