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

Model Number 112264-001

Device Problems Crack (1135); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported the device was cracked and there was air within the device.A 2.1mm jetstream® xc atherectomy catheter was selected for an atherectomy procedure.During preparation outside the patient, it was observed that there was a lot of air in the device.Once the device was removed, it was noticed that the roller tubing was cracked.The device never went inside the patient.The procedure was completed with a different device.There were no patient complications and the patient was fine.

Manufacturer Narrative

Device evaluated by mfr.Returned product consisted of a jetstream xc-2.1 atherectomy catheter in one piece.The device was checked for any damage or leaking issues.During functional testing, it showed a leak from the infusion side of the baton.Closer examination showed evidence that the device was improperly inserted into the console and the door was shut and cracked the tubing when force was applied to try and close the door completely.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.Bsc id # (b)(4) / tw # (b)(4).

Event Description

It was reported the device was cracked and there was air within the device.A 2.1mm jetstream® xc atherectomy catheter was selected for an atherectomy procedure.During preparation outside the patient, it was observed that there was a lot of air in the device.Once the device was removed, it was noticed that the roller tubing was cracked.The device never went inside the patient.The procedure was completed with a different device.There were no patient complications and the patient was fine.

• 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: 6667124
• MDR Text Key: 78467841
• Report Number: 2134265-2017-06579
• 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: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2016
• 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