MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK JETSTREAM® XC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 112264-001

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that there was a hole in the catheter.A 2.1mm jetstream xc atherectomy catheter was selected for an atherectomy procedure in the superficial femoral artery.During the procedure, it was noted that the "clear coating" on the catheter shaft was raised for an area approximately an inch long but attached on both ends.It did not come off.Aspiration was in use but not negatively affected.During removal from the patient, the device was leaking at that spot as if a hole was in the catheter and saline was dripping out.The procedure was completed with a different device.There were no patient complications and the patient's condition was fine.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the lesion was heavily calcified and extremely difficult.There was difficulty in advancing the catheter.The raised "clear coating¿ on the catheter shaft was noticed after the withdrawal of the catheter from the patient.The case lasted 5 hours.

• Brand Name: JETSTREAM® XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6606179
• MDR Text Key: 76712823
• Report Number: 2134265-2017-05402
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130637
• 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: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 112264-001
• Device Catalogue Number: PV31300
• Device Lot Number: 19983539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2016
• 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