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

Model Number 2200-3015

Device Problems Material Rupture (1546); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

The angiosculpt device ruptured when inflated to 26 atm, which is above rbp (18 atm).During removal, the device got stuck in the lesion and separated.The distal portion of the device was retained in the patient and resulted in open heart surgery for removal.Patient is doing well.No product evaluation performed.The proximal end of the angiosculpt device was disposed by the hospital.The distal portion that was removed from the patient was sent to pathology.The angiosculpt device was used off-label.The ifu warns to not exceed the rated burst pressure as indicated on the product label.

Event Description

Physician treated patient with two layers of stent- isr at mid lad.Physician first lased with a.9, but would not cross the distal lesion.Next, a nc balloon was used but ruptured at the lesion spot.Then, a rotoblator was used and able to cross the lesion.Finally, a 3 x 15 mm angiosculpt rx device was inflated to 26 atm and ruptured.During removal, the device separated and the balloon and hypotube was left in the mid lesion location.The physician tried to snare, but was unsuccessful after two hours.The patient was sent for open heart surgery.The balloon and hypotube were extracted without patient complication and is doing well.The physician commented that he probably should not have been so aggressive with the balloon.

Manufacturer Narrative

User facility report was received on 10/30/2017.Information states that the event outcome was death.Additional information received on 11/09/2017: from the spnc rep: during the procedure on (b)(6) 2017, an impella device was first placed to help pump blood from the lv to the body because the heart was too weak.From the physician: the patient survived the surgery, but thrombosed the left iliac system after the impella was removed.

• 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: 6906834
• MDR Text Key: 87875107
• Report Number: 3005462046-2017-00021
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2017

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: 07/26/2020
• Device Model Number: 2200-3015
• Device Catalogue Number: 2200-3015
• Device Lot Number: G17070038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2017
• Initial Date FDA Received: 10/02/2017
• Supplement Dates Manufacturer Received: 10/30/2017
• Supplement Dates FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2017
• 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- 0.014" GUIDE WIRE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR