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

Model Number 2200-3515-B

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

The patient's dob or age at time of event, gender, weight, ethnicity, and race are unknown.This information was not available from the facility.During inflation, the balloon ruptured at rbp.No patient injury reported, this mdr is being reported conservatively.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.The angiosculpt device was discarded by the facility, thus no returned product investigation was performed.

Event Description

The angiosculpt device was used to treat a severely calcified proximal lad.During inflation at rbp, the balloon ruptured.The procedure was completed with a balloon and a planned stent placement.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 ; 510673-223
• MDR Report Key: 11263184
• MDR Text Key: 258847875
• Report Number: 3005462046-2021-00006
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 00813132026936
• UDI-Public: 00813132026936
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2021

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: 09/17/2021
• Device Model Number: 2200-3515-B
• Device Catalogue Number: 2200-3515-B
• Device Lot Number: V20090022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2020
• 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