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

Catalog Number	HW35SS
Health Effect - Clinical Codes	Edema (1820); Swelling (2091); Blood Loss (2597)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the wire and stent (b)(4) coiled in the renal pelvis.A left ureteral stent was attempted.Under fluoroscopy as the wire was being removed the stent appeared to be bending and pleating over the wire.At this time the stent but was not disengaged from the wire.Several attempts were made to pull the wire out of the stent, and it would not disengage.Ultimately the wire and stent were removed through the penis.The wire appeared to have been embedded and engaged halfway through the stent., the stent was then cut.Another attempt was made to thread a wire through this stent using a hydrophilic wire but unfortunately the tip of the remaining stent was in the bladder and had already disengaged the ureteral orifice.The cystoscope was then replaced and it was noted the process of removing the stent had caused considerable swelling and edema around the left ureteral orifice which was also bleeding.The patient was admitted to observation and had at placement of a percutaneous nephrostomy tube.

• Brand Name: SOLO PLUS HYBRID GUIDEWIRE
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): HERAEUS MEDICAL COMPONENTS, LLC; 2605 fernbrook lane north; suite j; plymouth MN 55447
• MDR Report Key: 9227263
• Report Number: 2315342-2019-00004
• Device Sequence Number: 11321101
• Product Code: EZB
• UDI-Device Identifier: 00816840020296
• UDI-Public: (01)00816840020296
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2022
• Device Catalogue Number: HW35SS
• Device Lot Number: PL06804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 164