MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW); CATHETER, ANGIOPLASTY, PERIPHERAL

Model Number 2155-3040

Device Problems High Test Results (2457); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2016

Event Type  malfunction  

Manufacturer Narrative

Lab analysis confirmed an overflow lifting of material at the distal bond but it remained intact to the device.Recurrence of the malfunction could result in a mild vessel injury (non-flow limiting dissection).(b)(4).The angiosculpt was returned for evaluation.Visual inspection confirmed an elevated scoring element at the distal end.In addition, an overflow lifting of material was observed at the distal bond but it remained intact to the device.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.

Event Description

The plan was to use 2 angiosculpt balloons: 3 x 40 mm and a 3 x 15 mm.After the 3 x 40 mm was removed from the patient, the nitinol scoring element was slightly elevated at the tip of the balloon.The procedure was completed with the 3 x 15 mm angiosculpt device.No additional time and no patient injury associated with this complaint.Note: lab analysis performed on (b)(6) 2016 found an overflow lifting of material at the distal bond.

Manufacturer Narrative

The patient codes and device code were not included in the initial mdr.

• Brand Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 5940682
• MDR Text Key: 54776468
• Report Number: 3005462046-2016-00022
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101735
• 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,Followup
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2019
• Device Model Number: 2155-3040
• Device Catalogue Number: 2155-3040
• Device Lot Number: G16050001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2016
• 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
• Treatment: UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Outcome(s): Other