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

Model Number	2155-3040
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the returned product investigation, it was observed that the scoring element rings detached from the distal bond, but remained intact to the device.Recurrence of the malfunction could result in a mild vessel injury (non-flow limiting dissection).Patient information regarding relevant tests/laboratory data or medical history is unknown.This information was not available from the facility.The angiosculpt device was returned for investigation.Visual examination found the distal scoring element rings detached from the distal bond, however it remained intact at the intermediate bond.The distal balloon was inverted and the distal shaft was stretched between the proximal balloon and intermediate bond.During functional testing, the balloon was inflated to 6 atm and a pinhole leak was observed at the distal end.Based on the returned product evaluation, it is probable that the detached scoring element was due to the improper handling during use.
Event or Problem Description
The angiosculpt device ruptured while being inflated at 18 atm.The device was removed with no patient injury.The procedure was completed with a csi and 4.5 x 120 mm supera stent, then post dilated with 4 x 40 mm rapidcross catheter.Note: returned product investigation found the scoring element rings detached from the distal bond.
Additional Manufacturer Narrative
Additional information was received on 26sep2018: patient information.Other relevant history: pre-existing medical conditions.Concomitant medical products: added guide wire size and introducer sheath info, no guide catheter used.

• 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: 7890095
• Report Number: 3005462046-2018-00021
• Device Sequence Number: 2366041
• Product Code: PNO
• UDI-Device Identifier: 00813132021320
• UDI-Public: 00813132021320
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101735
• 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,Followup
• Report Date (Section B): 08/10/2018
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2019
• Device Model Number: 2155-3040
• Device Catalogue Number: 2155-3040
• Device Lot Number: G16010021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 10/01/2018
• 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: MEDTRONIC: COUGAR 0.014" GUIDE WIRE; MEDTRONIC: COUGAR GUIDE WIRE, SIZE UNK; TERUMO: 6F DESTINATION SHEATH; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Weight: 117
• Date Report Sent to FDA: 01/01/2005