MAUDE Adverse Event Report: HERAEUS MEDICAL COMPONENTS SOLO PLUS HYBRID GUIDEWIRE; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number HW35SAJ

Device Problem Material Separation (1562)

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

Event Date 04/19/2021

Event Type  malfunction  

Event Description

It was reported that the flexible part of the tip ruptured which was observed after the completion of endoscopic combined intrarenal surgery while the guidewire was pulled out.Considering the possibility of rupture, the indwelling stent was removed and an x-ray was taken, but there were no signs of residue in the body.The stent was removed and cut with a scalpel and confirmed that the tip of the guidewire remained in the stent.Lot unknown.Complaint received via ibc on (b)(6) 2021.(b)(4).Based on the reported issue, all information needed for the investigation to be conducted has been received.Therefore, no additional follow up attempts will be made.(b)(4).Per mail notification received on 16sep2021, updated the plant number and plant description.(b)(4).

• Brand Name: SOLO PLUS HYBRID GUIDEWIRE
• Type of Device: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): HERAEUS MEDICAL COMPONENTS; 5030 centerville road; st. paul MN 55127
• Manufacturer (Section G): HERAEUS MEDICAL COMPONENTS, SRL; parque industrial zona franca; la lima guadalupe building 29; cartago, costa rica 30106 ; CS 30106
• Manufacturer Contact: tim desaulniers ; 5030 centerville road; st. paul, MN 55127 ; 6123252003
• MDR Report Key: 12842662
• MDR Text Key: 282123504
• Report Number: 3008988055-2021-00004
• Device Sequence Number: 1
• Product Code: EZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HW35SAJ
• Device Catalogue Number: HW35SAJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2021
• 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): Other