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

Model Number	AB35SX040200135
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2020
Type of Reportable Event	Serious Injury
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.Placement of a new introducer sheath and stellarex device was required, resulting in a prolonged procedure.No patient injury reported.Patient information regarding relevant tests/laboratory data or medical history are 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, if resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to the device or lumen.Carefully withdraw the catheter.
Event or Problem Description
The stellarex device was used to treat a severely calcified and a severely tortuous proximal cfa.The physician attempted to load the stellarex over three different size guide wires (014, 018, 035), but was unable to pass all the way through the 6f terumo destination sheath.The stellarex was removed from the 035 guide wire, which remained in the patient.The physician then removed the introducer sheath and replaced it with a new introducer sheath.At that point, a new stellarex was loaded over the existing 035 guide wire and was able to pass through the new introducer sheath with no issues.When the first stellarex was removed from the patient, the physician did not attempt to load the new stellarex through the first introducer sheath.Therefore, it is unknown if the stellarex was unable to pass due to an occluded guide wire lumen (preventing the stellarex to advance past the introducer sheath) or an occluded introducer sheath.

• 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: 10394216
• Report Number: 3009784280-2020-00226
• Device Sequence Number: 11624724
• Product Code: ONU
• UDI-Device Identifier: 00813132026455
• UDI-Public: 00813132026455
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2020
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2021
• Device Model Number: AB35SX040200135
• Device Catalogue Number: AB35SX040200135
• Device Lot Number: F4J19K21A
• Was Device Available for Evaluation?: No
• 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: 07/14/2020
• Initial Report FDA Received Date: 08/11/2020
• 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: Hospitalization; Required Intervention
• Date Report Sent to FDA: 01/01/2005