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

Model Number 2200-2515

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

The patient's dob, age at time of event, gender, or weight are unknown.This information was not available from the facility.During withdrawal, the angiosculpt device separated in two pieces.Recurrence of the malfunction could result in a prolonged procedure.No piece of the angiosculpt device was retained in the patient.Patient information regarding medical history is unknown.This information was not available from the facility.Foreign- (b)(6).The angiosculpt device was returned in two pieces.The device separated at the proximal shaft approximately 19 cm distal to the strain relief.Based on the complaint details, the angiosculpt device got stuck on the lesion.It is likely that some degree of force was applied by the user, resulting in the shaft separation.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.

Event Description

The angiosculpt device was used to treat the proximal lad, but was unable to advance distally to the lesion.During withdrawal, resistance was noted and the device was unable to be removed from the lesion.As a result, the device snapped in two pieces, but was able to be removed from the patient, leaving the guide wire in place.The procedure was completed with a competitor balloon.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: 9528624
• MDR Text Key: 185501250
• Report Number: 3005462046-2019-00017
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 00813132021184
• UDI-Public: 00813132021184
• Combination Product (y/n): Y
• Reporter Country Code: KS
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,12/08/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2020
• Device Model Number: 2200-2515
• Device Catalogue Number: 2200-2515
• Device Lot Number: G17050056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• 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
• Initial Date Manufacturer Received: 12/08/2019
• Initial Date FDA Received: 12/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2017
• 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