MAUDE Adverse Event Report: PHILIPS IMAGE GUIDED THERAPY CORPORATION STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON; DCB PTA CATHETER

Model Number	AB35SX060120135
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient''s dob is unknown.This information was not available from the facility.Patient information regarding medical history is unknown.This information was not available from the facility.The stellarex device was infectious and discarded by the facility, thus no returned product investigation was performed.
Event or Problem Description
The stellarex device was delivered to the slightly calcified proximal sfa with no resistance.The balloon was pressurized to 8 atm, but did not appear to inflate completely.After inflation, the balloon would not deflate and had to stick a needle in the sfa, resulting in approximately a 15 minute delay.The procedure was completed with no patient injury reported.This adverse event and product problem is being submitted due to the balloon unable to deflate requiring intervention.
Additional Manufacturer Narrative
Blocks d1/ g1: manufacturer name and address was updated from the spectranetics corporation, 5905 nathan ln n, plymouth, mn 55442 to philips image guided therapy corporation, 9965 federal drive, colorado springs, co 80921 to match the information on the product label.
Additional Manufacturer Narrative
Blocks d1/ g1: manufacturer address was updated from 9965 federal drive, colorado springs, co 80921 to 5905 nathan lane north, plymouth, mn 55442.This correction was made to align the address with the fda registration number.

• Brand Name: STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
• Common Device Name: DCB PTA CATHETER
• Manufacturer (Section D): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 5905 nathan lane north; plymouth MN 80921
• Manufacturer (Section G): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 5905 nathan lane north; plymouth MN 80921
• Manufacturer Contact: ana tan ; 5905 nathan lane north; plymouth, MN 55442
• MDR Report Key: 14623173
• Report Number: 3016257349-2022-00001
• Device Sequence Number: 5013685
• Product Code: ONU
• UDI-Device Identifier: 00813132028992
• UDI-Public: 00813132028992
• Combination Product (Y/N): Y
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P160049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2023
• Device Model Number: AB35SX060120135
• Device Catalogue Number: AB35SX060120135
• Device Lot Number: P3422A14A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 05/09/2022; 05/09/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 05/08/2023; 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHILIPS: 0.014" PHOENIX LIGHT SUPPORT GUIDEWIRE.; TERUMO GUIDE CATHETER SIZE UNK.; TERUMO: 7F DESTINATION INTRODUCER SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White