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

Model Number 2333-8040

Device Problem Deflation Problem (1149)

Patient Problem Tissue Damage (2104)

Event Date 02/15/2016

Event Type  Injury  

Manufacturer Narrative

During removal, the angiosculpt separated in three pieces.Surgical intervention was required to remove the separated balloon from the patient resulting in prolongation of the procedure.Patient information regarding relevant tests/laboratory data or medical history is unknown.This information was not available from the facility.(b)(4).The angiosculpt was returned in three pieces (balloon, transition tubing, and shaft).Visual examination found the scoring elements struts slightly lifted from the distal bond.The intermediate bond was damaged and the scoring element rings were exposed.The transition tubing was necked, stretched, and separated from the intermediate bond and the proximal bond.In addition, the distal shaft was necked, stretched, and separated from the catheter shaft.The proximal bond was damaged and the inner member broke proximal to the proximal marker band which was located at the shaft.Based on the complaint information and the lab analysis, it is probable that the excessive force applied by the user contributed to the device separation.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.

Event Description

Prior to the use of the angiosculpt, ivus performed on the subclavian vein to treat patient with post thoracic outlet syndrome.The angiosculpt was loaded over a 0.014" ironman guide wire and introduced through 9 french, 10 cm terumo introducer sheath through the brachial vein.The angiosculpt was inflated three times at 12 atm for an average of 30 seconds each.The angiosculpt was removed and a venogram showed thrombus retained in the axillary vein.The angiosculpt was then reinserted and inflated four additional times at 30 seconds each.During removal, the balloon was unable to deflate and could not pass through the introducer sheath.Excessive force was applied to remove through the introducer sheath but the balloon detached from the shaft and was left in the brachial vein where it was surgically removed thru brachial cut down.

Manufacturer Narrative

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

• Brand Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL
• Manufacturer (Section D): ANGIOSCORE, INC; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): ANGIOSCORE, INC
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 5504297
• MDR Text Key: 40489277
• Report Number: 3005462046-2016-00009
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150634
• 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: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2016
• Device Model Number: 2333-8040
• Device Catalogue Number: 2333-8040
• Device Lot Number: G15090039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2015
• 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- 9F 10 CM INTRODUCER SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR