MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION ANGIOSCULPT OTW PTA; CATHETER, PTA, CUTTING/SCORING

Model Number	2076-6020
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The angiosulpt device was used to treat a peripheral lesion.During the first inflation below rbp, the balloon did not inflate.Upon removal outside of the patient's body, a leak from the tip was observed, but could not confirm exact location of the leak.The procedure was completed with a new angiosculpt.No patient injury reported.This product problem is being submitted conservatively because the balloon may have ruptured below rbp.
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.Attempts to obtain the information has not been successful.Foreign: (b)(6).The angiosculpt device has not been returned by the facility, thus no returned product investigation was performed.
Additional Manufacturer Narrative
Block b1/b5/h1: based on the returned product evaluation, this is no longer reportable for a product problem.Block d9/g3: the angiosculpt device was returned for evaluation.Block h3: visual inspection found a bent distal tip, a damaged balloon with the distal end inverted, and a deformed scoring element.During functional testing, using an indeflator filled with green color dye water, the device was pressurized to nominal (8 atm) and a hub leak was present at the guidewire port.The balloon was able to inflate with a misaligned scoring element noted.No balloon rupture was observed.Block h6: a balloon rupture could not be confirmed.However, a hub leak was noted, but unable to determine the root cause of the observed failure.A review of the dhr and manufacturing process could not confirm a cause related to design and/or process failure.
Event or Problem Description
This product problem is no longer reportable because no balloon rupture was observed during the returned device evaluation.
Additional Manufacturer Narrative
Block h6: component code corrected from 419 (balloon) to 4761 (access port) based on the returned device evaluation stated in supplemental report #1.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
• Common Device Name: CATHETER, PTA, 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
• MDR Report Key: 13689454
• Report Number: 3005462046-2022-00015
• Device Sequence Number: 1943391
• Product Code: PNO
• UDI-Device Identifier: 00813132021382
• UDI-Public: 00813132021382
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2022

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: 06/06/2022
• Device Model Number: 2076-6020
• Device Catalogue Number: 2076-6020
• Device Lot Number: G19060007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/15/2022
• Supplement Date Received by Manufacturer: 03/16/2022; 07/18/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/08/2022; 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2019
• 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: BOSTON SCIENTIFIC: 0.014" AGURU GUIDEWIRE; TERUMO: 6F RADIOCUS INTRODUCER SHEATH
• Patient Sex: Unknown