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

Model Number	2216-30100
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2018
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 was unable to deflate.Additional intervention was required to remove from the patient.Patient information regarding relevant tests/laboratory data or medical history are unknown.The information was not available from the facility.The angiosculpt device is available for evaluation, but has not yet been returned.The angiosculpt device has not yet been returned, thus product investigation will be completed upon receipt.
Event or Problem Description
The angiosculpt device was inflated below rbp with no issues.During removal, the balloon was unable to deflate.The physician inflated the balloon and deflated multiple times and eventually the balloon was able to deflate approximately 10 minutes later.The balloon, guidewire, and sheath were removed as a unit from the patient.The procedure was completed with another balloon.
Additional Manufacturer Narrative
The angiosculpt device was returned intact to a guide catheter that was connected to a stopcock.The guide catheter could not be removed, thus was pushed back towards the proximal end of the device.Visual examination found the scoring element rings detached from the distal bond, but remained intact at the intermediate bond.The balloon was inverted at the distal end and the inner member was stretched with the proximal marker band located near the balloon taper.The transition tubing was damaged and the distal shaft was severely stretched.A shaft tear was observed and a kink was noted in the middle of the shaft.During functional testing, the balloon was pressurized with an indeflator, but unable to inflate.To determine the cause, the shaft was cut 10.5 cm proximal to the proximal bond.Using a stopcock, the balloon was pressurized with an indeflator, but inflation was not successful.Since the balloon was unable to inflate, the reported deflation issue could not be confirmed.Due to the nature of the returned device, it is probable that the cause of the balloon unable to deflate is due to the improper handling during use.Per the ifu, retained device component is a possible adverse effect of the procedure.

• 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: 7863870
• Report Number: 3005462046-2018-00020
• Device Sequence Number: 1171023
• Product Code: PNO
• UDI-Device Identifier: 00813132022914
• UDI-Public: 00813132022914
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K142983
• 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): 08/15/2018
• 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: 05/09/2020
• Device Model Number: 2216-30100
• Device Catalogue Number: 2216-30100
• Device Lot Number: G18050010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005