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

Model Number 2200-3015

Device Problems Entrapment of Device (1212); Material Frayed (1262); Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 12/29/2017

Event Type  Injury  

Manufacturer Narrative

The angiosculpt device ruptured when inflated to 22 atm, which is above rbp (18 atm).During removal, the device got stuck in the lesion and separated.Additional intervention was required to remove from the patient, thus resulted in a prolonged procedure.In addition, a dissection was noted.The lot number, expiration date, udi number, and device manufacture date are unknown.The lot number was not provided by the facility.The angiosculpt device was not returned, thus no evaluation performed.The angiosculpt device was used off-label.The ifu warns to not exceed the rated burst pressure as indicated on the product label.Per the ifu, coronary artery dissection is listed as a possible adverse effect of the procedure.

Event Description

The angiosculpt device was used to treat a sequential lad lesion.Both lesions were pre-dilated with rotablation, but the second lesion was highly calcified and would not dilate.An angiosculpt device was inflated to 22 atm, but ruptured in the second lesion and was entrapped in the artery.The angiosculpt would not pull back through the first lesion or advance forward through the second lesion.A wire was placed around the balloon to try and dilate the first lesion to help pull through, but did not work.The end of the angiosculpt was cut off and placed a guide liner over it, buried the guide and pulled, which snapped the catheter shaft.A balloon was placed into the guide liner, inflated to trap the remaining catheter of the balloon, buried the guide and the whole thing came out.Upon removal, the scoring element looked frayed, probably due to the balloon rupture, and as it was coming back through the first lesion, it hooked on a small dissection.The case was finished with excellent angiographic result.The patient was fine and went home the following day.

• 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
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 7229359
• MDR Text Key: 98629552
• Report Number: 3005462046-2018-00003
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• 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
• Report Date: 01/08/2018

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 Model Number: 2200-3015
• Device Catalogue Number: 2200-3015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2018
• Initial Date FDA Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 69