MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDEWIRE 1.5 X 229 (9 ); PASSER

Model Number 72202810

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the guidewire rubber nib protector would not come off.The incident occurred before the procedure.There was no significant delay and a backup device was available to complete the procedure with no complications reported.

Manufacturer Narrative

H3, h6: the reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: GUIDEWIRE 1.5 X 229 (9 )
• Type of Device: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11810541
• MDR Text Key: 250222216
• Report Number: 1219602-2021-01103
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00885554000207
• UDI-Public: 00885554000207
• Combination Product (y/n): N
• PMA/PMN Number: K885311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2024
• Device Model Number: 72202810
• Device Catalogue Number: 72202810
• Device Lot Number: 2024995
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1