MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, PTCA, CUTTING/SCORING

Model Number	2200-2015
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's gender, dob, age at time of event, or weight are unknown.This information was not available from the facility.The angiosculpt device was unable to fully deflate.Recurrence of the malfunction could result in a vessel obstruction or possible myocardial infarction.No patient injury.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.Report source: foreign- (b)(6).The angiosculpt device has not yet been returned, thus product investigation will be completed upon receipt.
Event or Problem Description
The angiosculpt device was unable to deflate completely after the first inflation.The balloon was carefully removed from inside the patient's body.No patient injury occurred.
Additional Manufacturer Narrative
Based on the returned product evaluation, no deflation issue was noted.However, the balloon was unable to re-wrap fully, which resulted in a larger balloon profile at the distal portion of the balloon.A larger balloon profile would cause difficulty retracting the device into the guide catheter, but recurrence of this malfunction does not result in patient injury.The angiosculpt device was returned for evaluation.Visual inspection found the balloon had been inflated, but did not appear partially inflated.In addition, the exit port was lacerated.During functional testing, the balloon was inflated/deflated multiple times with no deflation issues noted.The balloon was able to deflate within the time specification, however the distal portion of the balloon did not re-wrap fully, resulting in a larger balloon profile.The re-wrap issue is not a reportable malfunction of the device.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Common Device Name: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• MDR Report Key: 8574207
• Report Number: 3005462046-2019-00004
• Device Sequence Number: 2087105
• Product Code: NWX
• UDI-Device Identifier: 00813132021153
• UDI-Public: 00813132021153
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P050018
• 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,Followup
• Report Date (Section B): 04/11/2019
• 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: 05/30/2021
• Device Model Number: 2200-2015
• Device Catalogue Number: 2200-2015
• Device Lot Number: G18050036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/20/2019
• 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: BOSTON: FORTE GUIDE CATHETER SIZE UNK; NIPRO: PROFIT GUIDE WIRE, SIZE UNK; UNK MFG AND SIZE: INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005