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

Model Number	2076-5040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
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.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: foreign: (b)(6).Device evaluation anticipated, but not yet begun.
Event or Problem Description
The angiosculpt device was used to treat a moderately calcified mid sfa.During the first inflation before reaching nominal pressure, the balloon ruptured.The procedure was completed using a new angiosculpt device.No patient injury reported.This product problem is being submitted conservatively because the balloon ruptured below rbp.
Additional Manufacturer Narrative
Block g3/h3: the angiosculpt device was returned for evaluation.Block h3: visual inspection found no unusual characteristics of the device.During functional testing using an indeflator filled with green color dye water, the device was pressurized and at less than 2 atm, a leak on the balloon was present.Under microscopic inspection, a longitudinal balloon tear 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.

• Brand Name: ANGIOSCULPT OTW PTA
• Common Device Name: CATHETER, PTA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• MDR Report Key: 12345339
• Report Number: 3005462046-2021-00052
• Device Sequence Number: 3938189
• Product Code: PNO
• UDI-Device Identifier: 00813132021375
• UDI-Public: 00813132021375
• Combination Product (Y/N): Y
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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: 04/20/2023
• Device Model Number: 2076-5040
• Device Catalogue Number: 2076-5040
• Device Lot Number: G20040021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORDIS: 0.014" VASSALLO FLOPPY GUIDEWIRE.; MEDIKIT: 6F PARENT PLUS SHEATH/GUIDE.