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

Model Number 2001-3515

Device Problem Deflation Problem (1149)

Patient Problems ST Segment Elevation (2059); Decreased Respiratory Rate (2485); Vascular Dissection (3160)

Event Date 02/24/2020

Event Type  Injury  

Manufacturer Narrative

The patient's dob or age at time of event, and gender are unknown.Attempts to obtain the information has not been successful.During the procedure, the angiosculpt balloon was unable to deflate and caused a dissection, following the patient experienced inferior st elevation, decreased respiratory rate, and bradycardia.A stent was placed to treat the dissection, resulting in a prolonged procedure.Patient information regarding relevant tests/laboratory data, or medical history are unknown.Attempts to obtain this information has not been successful.Report source: foreign (b)(6).The angiosculpt device was returned attached to a 0.014" guide wire and inside an aortic radiology guide catheter.The distal tip was damaged and the distal portion of the balloon was inflated and exposed.The proximal portion of the balloon along with the shaft was stuck inside the guide catheter.The guide catheter was able to be pulled back towards the hub, exposing approximately 32 cm of the distal portion of the device.The proximal balloon appeared deflated and the intermediate shaft was severely stretched and twisted proximal to the rx port.During functional testing, the hub was connected to an indeflator to pull vacuum, but the balloon was unable to deflate.The balloon was pressurized and was able to inflate gradually (approximately 10 seconds) to 16 atm (rbp) for 1 minute and held pressure.The balloon was deflated, and after 2 minutes the balloon was still unable to fully deflate.This process was repeated with the same outcome.An attempt was made to remove the guide wire, but was not possible.The angiosculpt hub was then cut off, and the guide catheter was easily removed with no resistance, but the guide wire still could not be removed.The damaged intermediate shaft measured approximately 6 cm longer than spec.Next, the device was cut distal to the damaged intermediate shaft.A mandrel was inserted through the intermediate shaft to prevent the shaft from flattening and to allow it to be connected to a tuohy-borst for inflation.Using an indeflator, the balloon was able to inflate gradually (approximately 5 seconds) to rbp, but the balloon was unable to deflate.To investigate further, the transition tubing was removed to expose the proximal balloon leg and distal shaft.Under microscopic inspection, the proximal balloon leg was necked and the necked region measured approximately 2 mm in length.Using a snap gauge, the necked od measured approximately 0.008" less than the spec.To measure the inner diameter, the balloon leg was cut at the distal end of the necked area.Using a pin gauge, the necked region id measured approximately 0.006" less than the spec.The balloon leg was cut on the opposite end, where the balloon leg appeared normal, and both id and od measured within specification.(b)(4).Based on the lab analysis, the root cause of the deflation issue is due to a necked proximal balloon leg.Since there was no inflation issue, it is probable that poor handling of the device caused or contributed to the balloon deflation problem.Per the ifu, dissection is listed as a possible adverse effect of the procedure.

Event Description

The patient had 95% stenosis in the ostial/proximal right coronary artery (rca).A cordis jr4 guide catheter was positioned and inserted a 0.014" boston scientific samurai guide wire.The lesion was pre-dilated with a 3.0 mm nc balloon, followed by a 3.5 mm nc balloon, but the opening of the ostial artery was not good.The physician decided to use an angiosculpt device that was advanced to the lesion with no resistance.The balloon was inflated to 14 atm, with full expansion up to 15 atm with no issues.However, during retraction the balloon could not be deflated and caused a 25 mm long proximal dissection in the rca and the patient experienced inferior st elevation, decreased respiratory rate and bradycardia.The balloon was deflated again, and with some resistance it was possible to pull back to the aorta.At this point, the guide wire position was abandoned, and the angiosculpt was pulled back to the radial artery with the balloon stuck at the distal marker of the guide catheter.The full system was removed as a unit.To treat the dissection, a new jr4 guide catheter and a new samurai guide wire was positioned.The lesion was pre-dilated with a 3.0 nc balloon.Then a boston scientific choice pt2 used as a buddy wire, was placed to help with implantation of a 3.5 x 30 mm resolute integrity stent at 14 atm.For final post dilation of the entire stent, a 4.0 nc balloon was inflated to 20 atm.Primary results were good, no dissection noted, with good stent sizing expansion and wall opposition.Patient is doing well.

• 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: 9933329
• MDR Text Key: 186788333
• Report Number: 3005462046-2020-00006
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: M3702001351515
• UDI-Public: M3702001351515
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 01/01/2005,03/09/2020

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: 09/24/2021
• Device Model Number: 2001-3515
• Device Catalogue Number: 2001-3515
• Device Lot Number: F18090020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• 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: 03/09/2020
• Initial Date FDA Received: 04/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2018
• 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): Hospitalization; Required Intervention
• Patient Weight: 60