MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION ANGIOSCULPT RX PTCA; CATHETER, PTCA, CUTTING/SCORING

Model Number	2200-3010
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient''s dob or age at time of event, gender, weight, ethnicity, and race are 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.Report source: japan.The angiosculpt device was returned for evaluation; however, the device evaluation has not yet begun, thus a supplemental report will be filed 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
The angiosculpt device was used to treat a severely calcified mid lad.During the 3rd inflation at 18 atm (rbp), contrast leaked from the guidewire exit port.An attempt was made to deflate the balloon, but unable to remove the contrast.The device was pulled through the guide catheter, but could not be retrieved due to resistance.Several attempts were made to deflate the balloon, but only able to deflate a little bit.With force applied, the device was removed from the patient.The procedure was completed with a non-angiosculpt device.No patient injury reported.This product problem is being reported due to the balloon unable to fully deflate.There is a potential for harm with recurrence.
Additional Manufacturer Narrative
Block h3: the angiosculpt device was returned for evaluation.Visual inspection found no unusual characteristics of the device.During functional testing using an indeflator filled with green color dye water, the balloon was pressurized, but unable to hold pressure.A leak was observed on the distal shaft, opposite from the rx port.The balloon was able to deflate with no issues.Block h6: based on the lab analysis, the balloon deflation issue could not be confirmed.However, the shaft leak likely caused or contributed to the balloon unable to fully deflate, but the cause of the leak could not be determined.A review of the dhr and manufacturing process could not confirm a cause related to design and/or process failure.All devices are 100% leak tested during the manufacturing process.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 RX PTCA
• Common Device Name: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: ana tan ; 5055 brandin court; fremont, CA 94538 ; 510673-2239
• MDR Report Key: 16623844
• Report Number: 3005462046-2023-00011
• Device Sequence Number: 4457738
• Product Code: NWX
• UDI-Device Identifier: 00813132021207
• UDI-Public: 00813132021207
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P050018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2023
• Device Model Number: 2200-3010
• Device Catalogue Number: 2200-3010
• Device Lot Number: G20110018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2020
• 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: ASAHI: 0.014" SION BLUE GUIDEWIRE; MEDTRONIC: 7F LAUNCHER JL35; TERUMO: 6F GLIDESHEATH
• Patient Sex: Unknown