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

Model Number 2200-3015

Device Problems Break (1069); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2019

Event Type  malfunction  

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 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)
• Type of Device: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: ana tan ; 5055 brandin court; fremont, CA 94538 ; 510933-798
• MDR Report Key: 9154134
• MDR Text Key: 185503049
• Report Number: 3005462046-2019-00014
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 00813132021214
• UDI-Public: 00813132021214
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 85