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

Model Number	2200-3015
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During withdrawal the angiosculpt device separated in two pieces.Although the separated portion occurred outside of the body, this is being reported conservatively.Recurrence of this malfunction could result in a prolonged procedure.The angiosculpt device was returned in two pieces.The device separated at the proximal shaft approximately 14 cm distal to the strain relief.The rx port is lacerated and a kink was observed 3 mm proximal to the rx port.The ifu precautions to verify functionality and catheter integrity prior to angioplasty.It is likely the kink is the result of user mishandling, which caused or contributed to the device separation.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.
Event or Problem Description
Upon initial advancement into the body, a ''kink'' was noted at the proximal shaft.At that point, the advancement stopped and attempted to slightly inflate the balloon (to test it), to see if the balloon was patent, but it was not.The balloon was deflated and during withdrawal, there was little to no resistance noted, however, the stem (shaft) fully broke at the kink.The distal portion was still inside the body, but the proximal end was outside and able to be retrieved.The residual balloon stem (distal shaft) was removed with no excessive force applied.The guide wire remained in place and a different balloon was used to complete the procedure.No patient injury reported.

• 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: 9154134
• Report Number: 3005462046-2019-00014
• Device Sequence Number: 2547287
• Product Code: NWX
• UDI-Device Identifier: 00813132021214
• UDI-Public: 00813132021214
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• 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): 09/04/2019
• 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: 06/13/2022
• Device Model Number: 2200-3015
• Device Catalogue Number: 2200-3015
• Device Lot Number: G19060018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• 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: 09/16/2019
• Initial Report FDA Received Date: 10/03/2019
• 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: 74 YR
• Patient Weight: 85
• Date Report Sent to FDA: 01/01/2005