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

Model Number 2200-2515

Device Problems Detachment Of Device Component (1104); Deflation Problem (1149); Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/02/2017

Event Type  Injury  

Manufacturer Narrative

The angiosculpt balloon was unable to deflate fully and got caught on the lesion.During retraction, resistance was noted and upon removal, the device separated.Additional intervention was required to remove from the patient and a competitor device was used to complete the procedure, thus resulting in prolongation of the case.No patient injury reported.(b)(4).The angiosculpt device was not returned for evaluation, thus no product investigation was performed.Per the ifu, retained device components is listed as a possible adverse effect of the procedure.

Event Description

The angiosculpt balloon did not fully deflate and got caught on a lesion.Resistance was noted and there was difficulty removing the device through the introducer sheath.Upon removal, the angiossculpt separated from the guide wire.A snare was used to remove from the patient.No piece of the angiosculpt was retained in the patient.The patient did not require hospitalization and no patient injury reported.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Type of Device: CATHETER, PERCUTANEOUS, CUTTING/SCORING
• 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: 6664733
• MDR Text Key: 78313126
• Report Number: 3005462046-2017-00011
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• 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,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2019
• Device Model Number: 2200-2515
• Device Catalogue Number: 2200-2515
• Device Lot Number: G16100015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2016
• 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: TERUMO: 0.014" GUIDE WIRE; TERUMO: 6F GUIDE CATHETER; TERUMO: 6F INTRODUCER SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention