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

Model Number 2200-3010

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Death (1802)

Event Date 10/11/2018

Event Type  Death  

Manufacturer Narrative

During withdrawal, the distal shaft separated inside the patient.Additional intervention was performed to remove from the patient.No piece of the angiosculpt device was retained in the patient.Patient information regarding relevant tests or laboratory data are unknown.The information was not available from the facility.The cause of death is unknown.Although images showed no patient injury after the angiosculpt was removed from the patient, ''death'' was selected as a conservative measure.The angiosculpt device was returned without the distal portion (distal tip, distal bond, balloon, scoring element, intermediate bond, transition tubing, and proximal bond) and the entire inner member.The distal portion separated at the distal shaft approximately 15 cm distal from the rx port.The distal end where the device broke showed evidence of stretching.The inner member that separated along with the distal portion, separated just distal to the rx bond.The proximal shaft (hypotube) was bent and damaged with multiple kinks along the shaft and the strain relief was kinked.The angiosculpt device was used off-label.The ifu warns to not exceed the rated burst pressure as indicated on the product label.Based on the lab analysis, it is likely that excessive force was applied by the user that led to the device separation inside the patient.Per the ifu, retained device component is listed as possible adverse effect of the procedure.

Event Description

The angiosculpt device was used in a patient with in-stent restenosis (3 stents).Prior to the use of the angiosculpt device, a elca laser was used in a patient to soften the lesion to change morphology.Images post laser showed no dissection or perforation.Then, an angiosculpt device was inflated multiple times up to 30 atm, beyond the rbp of 18 atm.During removal, resistance was noted, thus force was applied and resulted in the distal portion of the device separating inside the patient.The separated portion was snared and removed successfully.No piece of the angiosculpt device was retained in the patient.Images post angiosculpt showed no dissection or perforation.Then, a regular balloon was inserted to optimize the luminal gain and a perforation was observed.Two graftmaster stents were placed to treat the perforation.Five days post procedure, information provided was that the patient expired.Date of death and cause of death are unknown.

Manufacturer Narrative

Information was provided by the facility on 01/25/2019.

Event Description

The patient died of cardiac arrest.

• 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: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 8033421
• MDR Text Key: 125981459
• Report Number: 3005462046-2018-00023
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 00813132021207
• UDI-Public: 00813132021207
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2018
• Device Model Number: 2200-3010
• Device Catalogue Number: 2200-3010
• Device Lot Number: G15120021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• 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: 10/11/2018
• Initial Date FDA Received: 11/02/2018
• Supplement Dates Manufacturer Received: 01/25/2019
• Supplement Dates FDA Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2015
• 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: 6F DESTINATION GUIDE CATHETER; TERUMO: 6F INTRODUCER SHEATH; UNK MFG: 0.014" GUIDE WIRE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 87