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

Model Number	2076-4040
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's dob, age at time of event, or weight is unknown.This information was not available from the facility.The angiosculpt device got stuck in the guiding sheath; therefore, the device and sheath were removed as a unit.Placement of a new sheath and balloon device was required to treat the patient, resulting in a prolonged procedure.In addition, the scoring element detached from the intermediate bond, but remained intact at the distal bond.Recurrence of the malfunction could result in a vessel dissection/perforation or may require surgical intervention for device removal.Patient information regarding relevant tests/laboratory data or medical history are unknown.The information was not available from the facility.Foreign - (b)(6).The angiosculpt device was returned with a y-adapter, connector tubing, stopcock, and sheath still intact.Visual examination found a damaged distal bond and disruption.The scoring element was detached from the damaged intermediate bond, but still intact to the distal bond.Three scoring element rings and all struts were bent at the distal end.In addition, the proximal end of the scoring element was severely mangled.The transition tubing was wrinkled and pulled distally over the balloon and proximal marker band.Multiple kinks were observed on the shaft.Due to the condition of the returned device, the proximal shaft was cut to allow removal from the sheath.Under microscopic inspection, damage was observed around the opening of the sheath.Based on the returned product evaluation, it is probable that the detached scoring element was due to improper handling during use.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 together with a rikishi guiding sheath to treat the sfa.Upon removal of the device, it got stuck inside the guiding sheath and the scoring element partially detached from the balloon.The device and the guiding sheath were removed as a unit from the patient with no injury.The procedure was completed with another balloon.

• 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: 8143883
• Report Number: 3005462046-2018-00025
• Device Sequence Number: 10817239
• Product Code: PNO
• UDI-Device Identifier: 00813132021351
• UDI-Public: 00813132021351
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K100303
• 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): 11/15/2018
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2021
• Device Model Number: 2076-4040
• Device Catalogue Number: 2076-4040
• Device Lot Number: G18040014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• 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: 11/15/2018
• Initial Report FDA Received Date: 12/07/2018
• 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: Hospitalization; Other
• Date Report Sent to FDA: 01/01/2005