MAUDE Adverse Event Report: WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB LOFRIC ORIGO; CATHETER STRAIGHT

Model Number	44312
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch records showed no signs of deviations.There is no previous complaint reported on the same lot.Complaint report included statements device was not suspected to be deficient.The used device was discarded and not returned.The returned unused catheters (surrogate devices) from the same lot and customer box were investigated with results as follows: visual inspection showed no signs of defects or deviations.Tests of coating sliperiness and coating friction, respectively, gave both results within specification limits.Instructions for use informs about the risk of bleedings in relation to urinary catheterisation therapy.Urethral damage is a known common adverse event for the therapy and specified in instructions for use.No root cause identified related to the device.The most probably root cause is considered to be related to the user concomitantly treated with anticoagulant therapy thereby being predisposed to bleeding more easily and severely if experiencing urethral damage.Further, as verified by clinical urology experts consulted during investigation of this case, urethral trauma with bleeding is a known risk during intermittent catheterisation (ic), which normally is mild and transient without medical intervention.In patients treated with anticoagulants (ac) the risk of prolonged bleeding is increased, which is well known by both the patients and healthcare professionals.Ic using atraumatic, hydrophilic catheters such as the device in question minimizes the risk of urethral trauma and bleeding.Patients in need of bladder management can often be on life-long treatment with ac, and the risk of prolonged bleeding is outweighed by the benefits of ic using hydrophilic catheters.
Event or Problem Description
Event occured in (b)(6), i.E.Outside usa.According to complaint reporter, the patient begun performing intermittent catheterization therapy, after training by healthcare professional on (b)(6) 2020 and without problems the first days at home.The patient, who is concomitantly treated with anticoagulant therapy, noticed a bleeding ((b)(6)) and on the day after he also noticed blood lumps in urine.When withdrawing a catheter on the same day a more severe bleeding developed.The patient visited his urologist to following day ((b)(6)).The urologist inserted an indwelling catheter and urinary collection bag.The bleeding developed more severely over night and the user was admitted to hospital ((b)(6)).The bleeding stopped.Patient was treated with antibiotics.Surgery is planned for the patient, to enable bladder management by other means than intermittent catheterization.The patient had reported he did not suspect any device deficiency.

• Brand Name: LOFRIC ORIGO
• Common Device Name: CATHETER STRAIGHT
• Manufacturer (Section D): WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB; aminogatan 1; p.o. box 14; moelndal, SE-43 121; SW SE-43121
• MDR Report Key: 9828351
• Report Number: 3009632672-2020-00004
• Device Sequence Number: 727737
• Product Code: EZD
• UDI-Device Identifier: 07392532158292
• UDI-Public: 07392532158292
• Combination Product (Y/N): N
• PMA/510(K) Number: K122078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/23/2021
• Device Model Number: 44312
• Device Catalogue Number: 44312
• Device Lot Number: 447039
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/13/2020
• 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; Other