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

Model Number	2076-5020
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	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's dob, age at time of event, gender, or weight are unknown.This information was not available from the facility.During withdrawal, the proximal portion of the scoring element detached, but remained intact to the device.Recurrence of the malfunction could result in embolism or flow limiting dissection.Patient information regarding relevant tests/ laboratory data or medical history are unknown.This information was not available from the facility.Foreign- (b)(6).The angiosculpt device was returned for evaluation.Visual inspection found a distal bond peel with one leaflet lifted, but remained intact to the device.In addition, one scoring element strut was lifted at the distal bond and detached from the intermediate bond, causing free edges.Based on the complaint details, resistance was noted during withdrawal from the sheath.It is likely that some degree of force was applied by the user, resulting in the scoring element detachment.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.
Event or Problem Description
The angiosculpt device was used to treat the pulmonary artery and was inflated 3 times at less than 14 atm (rbp).During withdrawal through the sheath, resistance was met.Upon removal, the proximal portion of the scoring element was detached, but not totally separated.The procedure was completed with another angiosculpt device.No patient injury reported.

• 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: 9614189
• Report Number: 3005462046-2020-00002
• Device Sequence Number: 2677432
• Product Code: PNO
• UDI-Device Identifier: 00813132021368
• UDI-Public: 00813132021368
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K110767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/24/2019
• 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: 04/19/2020
• Device Model Number: 2076-5020
• Device Catalogue Number: 2076-5020
• Device Lot Number: G17040035
• Was Device Available for Evaluation?: Yes
• 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: 12/24/2019
• Initial Report FDA Received Date: 01/21/2020
• 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
• Date Report Sent to FDA: 01/01/2005