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

Model Number	2249-60200
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Failure to Deflate (4060)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block a3b: the patient's gender is unknown.This information was not available from the facility.Patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Device evaluation and investigation is currently ongoing.A supplemental mdr will be submitted upon completion.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
An angiosculpt catheter was used to treat a moderately calcified proximal lesion.The catheter was loaded over a non-philips guidewire where resistance was encountered.The balloon was inflated to 10 atm in the sfa and popliteal with no issues, but was unable to deflate; thus, a needle was used to pop the balloon through the skin.During removal, further resistance was noted, and the scoring element separated, while the rest of the catheter was removed together with the guidewire.Then, a snare was used to attempt removal but was unsuccessful.Therefore, the patient was transferred to the or for surgical removal.Imaging confirmed that no device fragments were left inside the patient.The procedure was completed, and the patient is doing well with no injuries reported.This adverse event and product problem is being submitted due to the balloon deflation and scoring element separation, requiring additional intervention.
Additional Manufacturer Narrative
Block h3: the angiosculpt device was returned without the scoring element.Visual inspection found damage to the distal tip, intermediate bond, and transition tubing.During functional testing, a 0.018" laboratory guidewire (same size used by the customer) was inserted, but unable to pass through the tip.The guidewire was switched to an 0.014" laboratory guidewire (correct size per product label), but encountered resistance at the distal portion of the balloon.With partial guidewire support, the balloon was inflated to 12 atm (rbp) and a pinhole leak was observed, which confirms the user punctured the balloon through the skin.To determine the cause of the guidewire resistance at the distal portion of the balloon, the device was visually inspected again and noted a wrinkled/accordioned inner member, along with a necked distal shaft.Block h6: the root cause of the balloon deflation issue and the scoring element separation could not be determined.However, a probable cause of the balloon unable to deflate may be due to the use of an oversized guidewire (0.018") causing resistance and damaging the inner member and distal shaft; collapsing the inflation lumen that prevented the balloon from deflating.Due to the resistance, it is possible that some degree of force was applied during removal, resulting in the separated scoring element.Additionally, per the ifu and product labeling, the angiosculpt device is compatible with an 0.014" guidewire.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.

• Brand Name: ANGIOSCULPT OTW PTA SCORING BALLOON CATHETER WITH HYDROCROSS COATING
• Common Device Name: CATHETER, PERCUTANEOUS, 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 ; 510933-4541
• MDR Report Key: 21339797
• Report Number: 3005462046-2025-00003
• Device Sequence Number: 3849588
• Product Code: PNO
• UDI-Device Identifier: 00813132021573
• UDI-Public: (01)00813132021573(17)260509(10)G24050009
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 03/05/2025

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: 05/09/2026
• Device Model Number: 2249-60200
• Device Catalogue Number: 2249-60200
• Device Lot Number: G24050009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2024
• 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: 0.018" COMMAND WIRE GUIDEWIRE; TERUMO: 6F INTRODUCER SHEATH; UNK MFG AND SIZE: GUIDE CATHETER
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American