MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UROPASS AS 11/13FR X 46 CM 5/BX; ACCEESSORIES, CATHETERS, G-U

Model Number	61146BX
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation.The definitive cause for the customer's experience can not be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
It is reported during a cystoscopy using a uropass access sheath, the distal five inches of the inner cannula separated and was retained inside the patient.Event details as follows: the doctor stated that the procedure started normally, with introducing the cystoscope to survey the bladder.He then placed a glidewire up the ureter, then placed a second wire up.Next, the access sheath was introduced.When the doctor removed the inner cannula of the access sheath, it was apparent the distal 5 inches of the inner cannula had detached.The procedure was not completed.A 5-inch segment of the distal end of the inner cannula was retained inside the patient.The patient reported pain due to the retained device fragment.On an unspecified date, the patient under went a second procedure during which the device fragment was removed with no further consequences reported.
Additional Manufacturer Narrative
This report is being updated to provide investigation findings.New information is reported in h4, h6, and h10.Corrected information is reported in h6 (type of investigation).Physical evaluation of the complaint device reveals: the dilator was broken into 4 pieces and the sheathing was intact.The broken dilator tip was not returned with the rest of the broken pieces.This would be consistent with the report of a piece being retained in the patient, which had to be later removed.There was also a small dent on the tip of the blue sheathing.The dilator clip was functional and the dilator could be inserted and removed smoothly within the sheathing.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.Conclusion: the root cause has been determined to be environmental exposure of the device, which resulted in degradation and embrittlement of the polymer.

• Brand Name: UROPASS AS 11/13FR X 46 CM 5/BX
• Common Device Name: ACCEESSORIES, CATHETERS, G-U
• Manufacturer (Section D): TELEFLEX MEDICAL OEM; 3750 annapolis lane north, suite 160; plymouth MN 55447
• MDR Report Key: 11131694
• Report Number: 3003790304-2021-00002
• Device Sequence Number: 4088936
• Product Code: KNY
• UDI-Device Identifier: 00821925035379
• UDI-Public: 00821925035379
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

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
• Operator of Device: Health Professional
• Device Model Number: 61146BX
• Device Lot Number: 09E1600089
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 04/05/2021
• 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 Age: 50 YR