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

Model Number 2200-3010

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

During inflation, the balloon ruptured below rbp.No patient injury reported, this mdr is being reported conservatively.Report source: foreign country: (b)(6).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 and moderately tortuous mid lad.During inflation, the balloon ruptured at 14 atm.The procedure was completed with a different device.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: 11303304
• MDR Text Key: 246295822
• Report Number: 3005462046-2021-00009
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 00813132021207
• UDI-Public: 00813132021207
• Combination Product (y/n): Y
• Reporter Country Code: TW
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2021

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: 01/16/2023
• Device Model Number: 2200-3010
• Device Catalogue Number: 2200-3010
• Device Lot Number: G20010019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• 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
• Patient Age: 69 YR
• Patient Weight: 73