MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW); CATHETER, PERCUTANEOUS, CUTTING/SCORING

Model Number	2249-60200
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During retraction, the angiosculpt device separated in two pieces.However, no piece of the device was retained in the patient and no injury reported.Recurrence of this malfunction could result in embolism or flow limiting dissection.Patient information regarding relevant tests/laboratory data or medical history are unknown.The information was not available from the facility.The angiosculpt device is with the hospital's risk management, thus no returned product evaluation was performed.It is likely that the force applied by the user caused or contributed to the device separation.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.
Event or Problem Description
The angiosculpt balloon was inflated to 8 atm with no issues.Upon removal, resistance was noted, thus force was applied and the distal shaft separated.The sheath, guide wire, and distal shaft were removed as a unit.No piece of the angiosculpt device was retained in the patient.No patient injury reported and no additional equipment or intervention was performed.

• Brand Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
• Common Device Name: CATHETER, PERCUTANEOUS, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• MDR Report Key: 9072210
• Report Number: 3005462046-2019-00012
• Device Sequence Number: 13890572
• Product Code: PNO
• UDI-Device Identifier: 00813132021573
• UDI-Public: 00813132021573
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K133998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2019
• Report Date (Section F): 01/01/2005

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: 01/08/2020
• Device Model Number: 2249-60200
• Device Catalogue Number: 2249-60200
• Device Lot Number: G18010010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Weight: 108
• Date Report Sent to FDA: 01/01/2005