MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CANNULARFK; PROBE, RADIOFREQUENCY LESION

Model Number RFK-C101018S-P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076)

Event Date 02/06/2018

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.

Event Description

A report was received that a patient developed a series of weals at the cannula insertion sites two weeks after the procedure.The physician believes the metal cannula tip or the sheath could be the cause; but indicates it is more likely that it is the sheath since it is in contact with the skin for much longer.It is unknown if any medical intervention was performed.Patient reaction has now settled.

Manufacturer Narrative

Initial reporter zip/post code: (b)(6).Patient identifier: ni.Device eval by manufacturer?: na.Device will not be returned.

Event Description

A report was received that a patient developed a series of weals at the cannula insertion sites two weeks after the procedure.The physician believes the metal cannula tip or the sheath could be the cause; but indicates it is more likely that it is the sheath since it is in contact with the skin for much longer.It is unknown if any medical intervention was performed.Patient reaction has now settled.

• Brand Name: CANNULARFK
• Type of Device: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): COSMAN MEDICAL, LLC; 22 terry avenue; ,; burlington MA 01803
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; ,; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7699833
• MDR Text Key: 114354526
• Report Number: 3006630150-2018-60207
• Device Sequence Number: 1
• Product Code: GXI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RFK-C101018S-P
• Device Catalogue Number: RFK-C101018S-P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention