MAUDE Adverse Event Report: MARTECH MEDICAL PRODUCTS, INC. DPIG HC 6X28; URETERAL STENT

Model Number 5606028

Device Problems Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Pain (1994); Injury (2348)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation.Therefore, the exact cause of the patient's alleged injuries could not be determined.However, if additional significant information becomes available, this report will be supplemented accordingly.

Event Description

Olympus received a legal document on april 20, 2020 which alleges that a patient was injured on (b)(6) 2018 during placement of an olympus urological stent to treat kidney stones.The patient stated that when the stent was inserted, the patient could not move her body without there being pain.The patient believes that the 6 x 28 urological stent was "too hard, too long in length, dangerous, and unsafe" for the use and manipulation which allegedly caused the patient's kidney injury.It was further alleged that at the time of the removal of the urological stent, the patient had apparently sustained a hematoma to the kidneys that required lifetime treatment with two different anticoagulants.As a result of the treatment with both anticoagulants, the patient had to undergo a hysterectomy in (b)(6) 2019.There was no surgery to treat the hematoma.

Manufacturer Narrative

This report is being updated to provide investigation findings and corrected information.A physical evaluation could not be performed because this device was not made available to the olympus.If the device becomes available, this complaint can be reopened.The device history record (dhr) was reviewed for this model and lot number, it was confirmed that involved lots of the reported part number were manufactured within specifications per customer requirements.No issues were detected during the visually and functionally inspections.Complaint data has been reviewed and there are currently no other open complaints for this product.Conclusion: definitive cause not established.

• Brand Name: DPIG HC 6X28
• Type of Device: URETERAL STENT
• Manufacturer (Section D): MARTECH MEDICAL PRODUCTS, INC.; 1500 delp drive; harleysville PA 19438
• MDR Report Key: 10077374
• MDR Text Key: 197102155
• Report Number: 3003790304-2020-00011
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K960148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 5606028
• Device Lot Number: MLBH560
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 12/23/2020
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 48 YR