MAUDE Adverse Event Report: INNOVEX MEDICAL CO. DONIER HOOVER NEGATIVE PRESSURE ACCESS SHEATH

Model Number	IVX-NS-1050
Medical Device Problem Codes	Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Perforation (2001)
Type of Reportable Event	Serious Injury
Event or Problem Description
A distributor emailed dmta and stated: "the doctor said he proceeded to place the access sheets with the introducer over the wire and the introducer punctured the ureter.Once the doctor recognized what took place, he had to place a stent and abandoned the case." the patient had the stent placed and was sent home.
Additional Manufacturer Narrative
It was reported that during placement of the hoover access sheath, the physician realized that the introducer had punctured the patient's ureter.The physician placed a stent and discontinued the procedure.The patient was then sent home.The dhr review confirmed that the lot was manufactured without variances or deviations and met all quality specifications prior to release.The product was not returned and was not available for evaluation.Past complaints were reviewed, and this is the first reported complaint for a hoover product puncturing a patient's ureter.Based on the information collected from the initial complainant and the oem, the injury may have been caused by excessive force and the patient's anatomy.The ifu identifies ureteral perforation as a potential adverse event, and the reported "tight ureter" may have been a contributing factor.

• Brand Name: DONIER HOOVER NEGATIVE PRESSURE ACCESS SHEATH
• Common Device Name: NEGATIVE PRESSURE ACCESS SHEATH
• Manufacturer (Section D): INNOVEX MEDICAL CO.; 315 qingda rd; 2nd floor, no. 17 building; shanghai, p.r. ; CH
• MDR Report Key: 25209738
• Report Number: 1037955-2026-00015
• Device Sequence Number: 16051121
• Product Code: FED
• UDI-Device Identifier: 00810116023615
• UDI-Public: 00810116023615
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/18/2026
• Report Date (Section F): 05/18/2026

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 Model Number: IVX-NS-1050
• Device Catalogue Number: IVX-NS-1050
• Device Lot Number: 251107202
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/05/2026
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2026
• 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: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/18/2026