MAUDE Adverse Event Report: SPECTRANETICS CORPORATION ANGIOSCULPT OTW PTA SCORING BALLOON CATHETER WITH HYDROCROSS COATING; CATHETER, PTA, CUTTING/SCORING

Model Number	2216-30100
Medical Device Problem Codes	Deflation Problem (1149); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block a4/a5: the patient's weight, ethnicity, and race are unknown.This information was not available from the facility.Block h3: the angiosculpt catheter was returned in two pieces.The catheter separated approximately 126 cm distal to the strain relief.The distal portion was returned stuck inside an introducer sheath.The distal portion includes the distal tip, distal bond, balloon, scoring element, intermediate bond, transition tubing, and proximal bond.Visual inspection found a tear on the balloon and the inner member, and the outer lumen (shaft) was detached at the proximal bond and sheered.The proximal portion was returned intact to an 0.014¿ guide wire and a syringe attached to the inflation port (hub).The proximal portion includes the hub, strain relief, and proximal shaft.Due to the nature of the returned catheter, the balloon deflation issue could not be confirmed.Block h6: based on the lab analysis, the balloon deflation issue could not be confirmed.Based on the complaint details, the shaft separation was the result of the excessive force applied by the user.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
The angiosculpt catheter was used to treat a moderately calcified proximal pt lesion.The balloon was inflated with no issues.After inflation, the balloon would not fully deflate after 5 minutes of applying negative pressure.The balloon seized on the guide wire and had to be withdrawn as a unit.Upon entering the sheath, resistance was noted, thus significant force was applied to withdraw the catheter from the guide wire.The catheter was able to be removed, but the distal portion of the balloon separated inside the sheath.An additional guide wire was attempted to assist with removal of the separated portion, but was not possible.The sheath was removed with the distal portion of the catheter within the sheath.No patient injury reported this is being reported due to the balloon unable to deflate and shaft separation requiring additional intervention to assist with removal.

• Brand Name: ANGIOSCULPT OTW PTA SCORING BALLOON CATHETER WITH HYDROCROSS COATING
• Common Device Name: CATHETER, PTA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: diana melliza galvez ; 5055 brandin court; fremont, CA 94538 ; 719377-8986
• MDR Report Key: 17650601
• Report Number: 3005462046-2023-00028
• Device Sequence Number: 15329059
• Product Code: PNO
• UDI-Device Identifier: 00813132022914
• UDI-Public: (01)00813132022914(17)240504(10)G22050008
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K142983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2023

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: 05/04/2024
• Device Model Number: 2216-30100
• Device Catalogue Number: 2216-30100
• Device Lot Number: G22050008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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: ABBOTT: 0.014" IRON MAN GUIDE WIRE; COOK: 6F HIGH FLEX ANSEL INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male