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

Model Number 2200-3015

Device Problems Break (1069); Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2017

Event Type  malfunction  

Manufacturer Narrative

During withdrawal, the angiosculpt device separated outside of the patient; thus no intervention was required.However, recurrence of this malfunction could result in a vessel obstruction, possible myocardial infarction requiring surgical intervention.(b)(4).The angiosculpt device was returned in two pieces.The shaft separated approximately 72" from the distal tip and a kink was observed on the hypotube.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.

Event Description

The angiosculpt worked fine in the patient during the intervention.During withdrawal, resistance was felt while pulling the device out of the guiding catheter but continued to pull and the shaft pulled apart, proximal to the balloon itself.

Manufacturer Narrative

In the initial mdr, it was noted that the shaft separated approximately 72" from the distal tip.This measurement was inadvertently transposed, the correct measurement is approximately 27" from the distal tip.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Type of Device: CATHETER, ANGIOPLASTY, CORONARY
• 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: 6296509
• MDR Text Key: 66657482
• Report Number: 3005462046-2017-00001
• 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,Followup
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2019
• Device Model Number: 2200-3015
• Device Catalogue Number: 2200-3015
• Device Lot Number: G16100050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 02/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2016
• 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): Other