MAUDE Adverse Event Report: COOK INC FLEXOR URETERAL ACCESS SHEATH AND DILATORS; KOE DILATOR, URETHRAL

Model Number	N/A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported that the physician was performing the ureteroscopy with laser and stone extraction procedure on a patient.While extracting stone fragments through flexor ureteral access sheath with the ngage nitinol stone extractor basket, the surgeon noticed strips of a plastic type material that were collecting in the sheath.The sheath was then removed along with the plastic material and a new flexor ureteral access sheath was introduced.The physician was able to remove all of the fragments from the end of the sheath.No unintended section of the device remained inside the patient¿s body.The patient did not require an additional procedure due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
\investigation - evaluation: a review of complaint history, review of device history record, instructions for use, and specifications were conducted during the investigation.Visual inspection and functional testing of the returned device were performed.A stone extractor handle was returned in the closed position with the basket fully deployed from the end of the basket sheath; the handle would not actuate basket formation.The basket sheath was smashed preventing basket from closing and retracting back into the basket sheath.A shaving of clear plastic like material was observed trapped on the end of the basket formation.The inside diameter of the flexor sheath was measured, this dimension is within specification tolerance.Under magnification damage to the distal edge of the flexor sheath was observed.Scrape marks and debris was also visualized inside the sheath tip.The shrink tube covering one of wires on the basket was also torn and pulled away from the wire.Fully expanded the basket formation is distorted, not centered.The basket appears to have been snagged during use pulling the wires out of proper formation.Evidence shows the damaged basket has caused damage to the inside of the flexor sheath by scraping the side of the sheath entangling the lining in the wires of the basket formation.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record found 2 other non-conformances associated with the complaint device lot number.These non-conformances are not related to the reported issue.This complaint is confirmed based on the physical evaluation of the returned device.Based on the provided information the root cause is related to product use or handling.Measures have been previously initiated to address this issue.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: FLEXOR URETERAL ACCESS SHEATH AND DILATORS
• Common Device Name: KOE DILATOR, URETHRAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6556501
• Report Number: 1820334-2017-00850
• Device Sequence Number: 16370070
• Product Code: KOE
• UDI-Device Identifier: 00827002348806
• UDI-Public: (01)00827002348806(17)200103(10)7560774
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K961904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: FUS-107045
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/17/2017
• Supplement Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR