MAUDE Adverse Event Report: BAYER INTERVENTIONAL JETSTREAM XC ATHERECTOMY CATHETER

Model Number 112266-001

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/27/2014

Event Type  Injury  

Event Description

A bayer r and i representative received that the jetstream catheter was being used to treat a calcified lesion when it locked up and stopped working.Upon removing the device, the physician kinked the guide wire and decided to cut it in order to remove the jetstream catheter.However, after the wire was cut and the catheter was removed, the physician noticed the part of the wire remained under the skin of the patient.The physician used a hemostat to retrieve the cut guide wire through the entry site in the groin.Additional information was received in which the physician treated the patient prophylactically with antibiotics after the procedure.There was no adverse event reported.Note: bayer and i became aware of this issue on (b)(6) 2014 at which time it was decided that this was not a reportable event.However, on (b)(6) 2014, we received information that, after further review, indicated that this event should now be reported.

Manufacturer Narrative

Product analysis received and examined the returned jetstream xc-2.4 catheter.Visual examination confirmed that the spyderwire guide wire was not stuck inside the catheter; however, a partial amount of the wire was returned with the device.It was noted that the baton and pod electrical plug had been removed from the catheter and were not returned.Product analysis could not functionally test the unit due to the removal of essential components from the jetstream catheter.Further examination of the guide wire lumen revealed that the proximal cap and bushing were plugged with teflon and fibrin.In this case the spyderwire guide wire is not listed in the jetstream system, ifu as a compatible device.This event is considered to be a reportable event as medical intervention was required to retrieve the cut guide wire and the physician chose to treat the patient prophylactically with antibiotics.

• Brand Name: JETSTREAM XC ATHERECTOMY CATHETER
• Type of Device: ATHERECTOMY CATHETER
• Manufacturer (Section D): BAYER INTERVENTIONAL; minneapolis MN
• Manufacturer Contact: diane eckert ; 9055 evergreen blvd nw; minneapolis, MN 55433 ; 7249408677
• MDR Report Key: 3812508
• MDR Text Key: 17989458
• Report Number: 2183460-2014-00006
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: 112266-001
• Device Catalogue Number: JETSTREAM
• Device Lot Number: 162373
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention