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

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

During inflation, the balloon ruptured.Recurrence of this malfunction could result in a prolonged intervention.No patient injury reported.Cross reference mfr report numbers: 3009784280-2019-00753, 3009784280-2019-00755.Patient information regarding relevant tests/laboratory data or medical history are unknown.The lot number was not provided by the facility, thus the following information are unknown: unique id, dose, model #, catalog #, expiration date, and manufacture date report source: foreign (b)(6).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 physician used two stellarex balloons and both ruptured during inflation before reaching rbp.

Manufacturer Narrative

Block d11: include guide wire size 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: 9522484
• MDR Text Key: 176412186
• Report Number: 3009784280-2019-00755
• Device Sequence Number: 1
• Product Code: ONU
• 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: 01/01/2005,02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE SIZE: 0.035".; MERIT MEDICAL: 6F INTRODUCER SHEATH.; TERUMO: GLIDEWIRE, SIZE UNK.; UNK MFG AND SIZE: GUIDE CATHETER.; UNK MFG AND SIZE: INTRODUCER SHEATH.
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 95