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

Model Number	2092-6040
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
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.Patient information regarding relevant tests/ laboratory data or medical history are unknown.This information was not available from the facility.Report source: foreign - (b)(6).The angiosculpt device has not been returned by the facility, thus no returned product investigation was performed.The angiosculpt device was used off-label.The ifu warns to not exceed the rated burst pressure (14 atm).In addition, an undersized introducer sheath (5f) was used.The instructions for use indicates the device is compatible with a 6f introducer sheath as indicated on the product label.
Event or Problem Description
The angiosculpt device was used to treat a slightly calcified peripheral lesion.During the second inflation at 18 atm for 5 seconds, the balloon ruptured.The procedure was completed with a new angiosculpt device.No patient injury reported.This product problem is being submitted because the balloon ruptured above rbp.There is potential for harm if it were to recur.
Additional Manufacturer Narrative
Block d9/g3: the angiosculpt device was returned for evaluation.Block g2 (correction): the initial mdr in section h11 indicated block g3.This was corrected to block g2.Block h3: visual inspection found a damaged distal bond with one leaflet lifted, but remained intact to the device.In addition, a longitudinal balloon tear on the entire length of the balloon was observed.Block h6: the ifu warns at least 99.9% of the balloons (with a 95% confidence level) will not burst at or below the rbp.
Additional Manufacturer Narrative
Block h6: in supplemental mdr #1, investigation conclusion code 22 "known inherent risk of device" and ifu statement in section h11 was inadvertently entered; therefore, conclusion code 22 does not apply.The conclusion code 18 "failure to follow instructions" from the initial mdr remains appropriate.

• Brand Name: ANGIOSCULPT OTW PTA
• Common Device Name: CATHETER, PTA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: diana melliza galvez ; 5055 brandin court; fremont, CA 94538
• MDR Report Key: 13210809
• Report Number: 3005462046-2022-00001
• Device Sequence Number: 19898022
• Product Code: PNO
• UDI-Device Identifier: 00813132021436
• UDI-Public: 00813132021436
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100303
• 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): 12/15/2021

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: 03/10/2024
• Device Model Number: 2092-6040
• Device Catalogue Number: 2092-6040
• Device Lot Number: G21030022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• 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: 12/15/2021
• Supplement Date Received by Manufacturer: 01/31/2022; 01/31/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 01/31/2022; 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2021
• 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: 0.018" FUGA GUIDEWIRE; MEDIKIT: 5F ULTRA HIGH FLOW INTRODUCER SHEATH
• Patient Sex: Unknown