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

Model Number	2216-25100
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The angiosculpt catheter was used to treat a slightly plaque distal anterior tibial artery.After inflation to 8 atm, the balloon was unable to deflate.An access needle was used to puncture the balloon through the skin in order to deflate the balloon.A 2.0 armada device was used to tamponade the area of the puncture site.The procedure was completed with the angiosculpt catheter.There was no patient injury reported.  this product problem and adverse event is being submitted due to the balloon deflation issue, requiring additional intervention.
Additional Manufacturer Narrative
Block a2/a3b/a4: the patient's dob, gender, and weight are unknown.This information was not available from the facility.Block b6: patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.Block h3: the angiosculpt device was returned for evaluation.Visual inspection found a damaged distal tip.Functional/subsequent testing identified the balloon was unable to inflate when pressurized to 8 atm (nominal).Further microscopic inspection found the distal portion of the balloon was kinked.To determine the cause, the proximal bond and the intermediate bond were dissected to separate the transition tubing from the bonds.This allowed the transition tubing to slide proximally over the catheter shaft, exposing underneath the distal shaft.For evidence of necking, using a snap gauge, measurements of the distal shaft od were obtained and showed 0.0315", which was below the acceptable specification of 0.0335" +/- 0.001".Using an indeflator filled with hot water, the balloon was pressurized to nominal but was unable to inflate due to a slow leak observed.Under microscopic inspection, a puncture on the balloon was confirmed, which aligns with the reported complaint that an access needle was required to deflate the balloon.Block h6: based on the device analysis, the reported complaint of the balloon unable to deflate could not be replicated due to the nature of the returned device (balloon punctured).However, necking was observed on the distal shaft that could have contributed to the balloon deflation issue, but the cause could not be established.A review of the dhr and manufacturing process could not confirm a cause related to design and/or process failure.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 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: 19510995
• Report Number: 3005462046-2024-00016
• Device Sequence Number: 11627064
• Product Code: PNO
• UDI-Device Identifier: 00813132022907
• UDI-Public: (01)00813132022907(17)250206(10)G23020008
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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: 02/06/2025
• Device Model Number: 2216-25100
• Device Catalogue Number: 2216-25100
• Device Lot Number: G23020008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• 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: 7F INTRODUCER SHEATH, UNK MFG; ASAHI: 0.014" REGALIA GUIDEWIRE
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White