MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UROPASS AS 11/13FR X 38 CM 5/BX; UROPASS ACCESS SHEATH

Model Number 61138BX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cyst(s) (1800)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

The access sheaths will not be returned to olympus for evaluation as the user facility discarded them following the procedure.The cause of the reported event cannot be confirmed.However, based on the reported information, the operator¿s technique cannot be ruled out as a contributory factor of the reported event.The reported event is listed as a potential complication that can occur during operation.The instruction manual (section 3.0) states, ¿patients or their representatives should be informed of the possible complications associated with the use of this product.Gyrus acmi requests that physicians notify the company of complications that may occur with the use of this device.Complications may include but are not limited to mucosal irritation, inflammation and perforation of the urethra, bladder, or ureter.¿ in addition, do not apply excessive force to the product or use it excessively.It is likely to injure or cause perforation in the urinary tract of the patient.The instruction manual states, ¿advance the dilator/sheath assembly over the guidewire to the desired location.If resistance is encountered, stop! do not advance against resistance.Damage to the anatomy could result.¿.

Event Description

Olympus was informed that on june 12, 2018 an olympus urf-v2 was inserted into the renal pelvic using a non-olympus rigid cystoscope, non-olympus guide wire, and an olympus access sheath, 61138bx.The physician determined that an access sheath of a thinner diameter was required; the physician changed to a 61046bx and the renal pelvic biopsy procedure was completed without issue.Following the renal pelvic biopsy procedure, a non-olympus stent was placed in the patient¿s ureter using a non-olympus rigid cystoscope and guide wire.After some time attempting to pass the guide wire through the ureteral opening, another doctor passed the guide wire and placed the ureteral stent.No olympus access sheath was used for the procedure of indwelling the stent.There were no malfunctions noted on the concerned equipment.On (b)(6) 2018, the stent was removed from the patient.On (b)(6) 2018, the patient visited the outpatient clinic due to a fever.During the visit they found ureteral damage as a urinary cyst had formed.On (b)(6) 2018, the stent was placed back in the ureter.On (b)(6) 2018, the urinary cyst was punctured and drained under a ct guide.On (b)(6) 2018 the stent was removed from the patient and the patient was discharged from the hospital.One of 2 devices.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.A dhr review was conducted for the reported lot number.There was no non-conformity or deviation detected during the manufacturing process.

• Brand Name: UROPASS AS 11/13FR X 38 CM 5/BX
• Type of Device: UROPASS ACCESS SHEATH
• Manufacturer (Section D): TELEFLEX MEDICAL OEM; 3750 annapolis lane north, suite 160; plymouth MN 55447
• MDR Report Key: 7912563
• MDR Text Key: 121919601
• Report Number: 2951238-2018-00576
• Device Sequence Number: 1
• Product Code: KNY
• Combination Product (y/n): N
• PMA/PMN Number: K051593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 61138BX
• Device Catalogue Number: 61138BX
• Device Lot Number: 09L1700121
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE (MAKE/MODEL/SN: UNK); OLYMPUS URF-V2, SN: (B)(4) ; RIGID TELESCOPE (MAKE/MODEL/SN: UNK)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 75