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

Model Number	2200-2515
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the returned device evaluation, a distal bond peel was observed, but remained intact to the device.Recurrence of this malfunction could result in an embolism, myocardial ischemia or infarction, or prolonged procedure.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 evaluation.Visual inspection found a distal bond peel with five leaflets lifted, but remained intact to the device.In addition, the intermediate shaft was flattened and stretched, which measured approximately 14 cm over the specification.No defect was noted on the hypotube.Based on the lab analysis, it is likely excessive exertion of force was applied by the user, resulting in the damage observed on the device.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.
Event or Problem Description
During use in patient, the angiosculpt device was defective.The hypotube was stretched out and became floppy.The procedure was completed with a new device and no patient injury reported.During the returned device evaluation on 10/10/2019, a distal bond peel was observed.

• 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: 9272687
• Report Number: 3005462046-2019-00015
• Device Sequence Number: 13870834
• Product Code: NWX
• UDI-Device Identifier: 00813132021184
• UDI-Public: 00813132021184
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P050018
• 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
• Report Date (Section B): 09/17/2019
• 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: 05/16/2022
• Device Model Number: 2200-2515
• Device Catalogue Number: 2200-2515
• Device Lot Number: G19050020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• 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: 10/10/2019
• Initial Report FDA Received Date: 11/04/2019
• 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
• Patient Age: 66 YR
• Patient Weight: 59
• Date Report Sent to FDA: 01/01/2005