MAUDE Adverse Event Report: COOK INC OPEN-END FLEXI-TIP URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Catalog Number	021305
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510k #: pre-amendment (b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.Medwatch: mw5080534.
Event or Problem Description
The user facility report # mw5080534 was received and the report showed the customer reported, a piece of the open-end flexi-tip ureteral catheter sheared off during case.It is believed that all pieces were removed from the patient.This is now the 3rd device issue with this product.Reference mdr # 1820334-2018-03443 and mdr# 1820334-2018-03444 for the other devices reported to have the same alleged malfunction.No adverse event have been reported as a result of the alleged malfunction.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the complaint device was not returned for an evaluation.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of complaint history, the device history record, manufacturing instructions, and quality control data.The device history record was reviewed.There were no non-conformances noted that would have caused or contributed to the reported failure mode.A search of complaint records revealed this complaint is the only one associated with complaint lot number 9048939.A review of the device history record did not identify any anomalies.No other customers have reported complaints on the same lot.The device was not returned; therefore, a returned device analysis could not be carried out.The cause of the complaint could not be established.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
Event or Problem Description
There has been no new information received since the last report was submitted.

• Brand Name: OPEN-END FLEXI-TIP URETERAL CATHETER
• Common Device Name: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8115599
• Report Number: 1820334-2018-03442
• Device Sequence Number: 1578307
• Product Code: GBL
• UDI-Device Identifier: 00827002145214
• UDI-Public: (01)00827002145214(17)210726(10)9048939
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2018

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 Expiration Date: 07/26/2021
• Device Catalogue Number: 021305
• Device Lot Number: 9048939
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1