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

Model Number 2200-2510

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problems Atherosclerosis (1728); Ischemic Heart Disease (2493)

Event Date 07/31/2018

Event Type  Injury  

Manufacturer Narrative

During withdrawal, the angiosculpt device got stuck in the lesion and separated at the distal shaft.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/laboratory data or medical history are unknown.The information was not available from the facility.The angiosculpt device is available for evaluation, but has not yet been returned.(b)(6).The angiosculpt device has not yet been returned, thus product evaluation will be completed upon receipt.Per the ifu, retained device component is a possible adverse effect of the procedure.

Event Description

Physician treated a high-risk patient with a sub-total stenosis in the lm, long stenosis in the proximal lad, and occluded rca.After several balloon dilitation attempts in the significantly calcified lad using a 2.75 mm nc balloon, the physician was unable to deliver a stent.The physician then decided to use a 2.5 mm x 10 mm angiosculpt ptca that was successfully delivered to the lad.The balloon was inflated several times to 10 atm, step-wise 2 atm.During withdrawal, the angiosculpt got stuck in the proximal lad and was unable to retrieve.The physician inflated the balloon several times at a low pressure of 4 atm without success.The guide wire was removed from the angiosculpt without friction.The physician then attempted to pull the catheter back, but the shaft separated and the distal part of the angiosculpt remained in the proximal lad and lm.The physician then intubated the vessel with a guide catheter and used a 2.5 mm sc balloon to "jail" the angiosculpt and was able to be removed.The vessel was then rewired and managed to intubate the lad successfully.The procedure was completed without any complications.No piece of the angiosculpt was retained in the patient.The patient is doing well and was transferred to a local hospital, as planned.

Manufacturer Narrative

The angiosculpt device was returned in two pieces without the scoring element.The scoring element separated from the distal bond and the intermediate bond.The transition tubing was wrinkled near the intermediate bond and detached from the proximal bond.The distal shaft was severely stretched and separated approximately 36 cm from the distal tip.The core wire was bent near the hypotube and multiple kinks were observed on the proximal shaft.The physician was notified of the missing scoring element and was unable to determine where the scoring element went.The angiosculpt device got stuck on a severely calcified lesion.The patient was high-risk with a sub-total stenosis in the lm, long stenosis in the proximal lad, and occluded rca.Due to the morphology, some degree of force was likely required to be removed from the patient, leading to the scoring element and distal shaft separation.

• 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
• MDR Report Key: 7791619
• MDR Text Key: 117424350
• Report Number: 3005462046-2018-00019
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 00813132021177
• UDI-Public: 00813132021177
• Combination Product (y/n): Y
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/01/2018

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: 12/13/2020
• Device Model Number: 2200-2510
• Device Catalogue Number: 2200-2510
• Device Lot Number: G17120016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• 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: 08/01/2018
• Initial Date FDA Received: 08/16/2018
• Supplement Dates Manufacturer Received: 09/12/2018
• Supplement Dates FDA Received: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASAHI- SION BLUE GUIDEWIRE, SIZE UNKNOWN; MEDTRONIC- 6F LAUNCHER EBU 3.5; TERUMO- 7F GLIDESHEATH SLENDER
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 76