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

Model Number AB35SX060120135

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2019

Event Type  malfunction  

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 Description

The balloon was pressurized to less than rbp, but would not hold pressure.A new stellarex device was used to complete the procedure.

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
• Type of Device: DCB PTA CATHETER
• Manufacturer (Section D): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• MDR Report Key: 9528630
• MDR Text Key: 176409501
• Report Number: 3009784280-2019-00759
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00813132023256
• UDI-Public: 00813132023256
• Combination Product (y/n): Y
• PMA/PMN Number: P160049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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.
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 97