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

Catalog Number	020015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that the open-end ureteral catheter was dry and kinked and then broke into two pieces when being inserted into the patient during a ureteral catheter placement procedure.One piece stayed inside and had to be removed.A second catheter was then used but the same incident occurred.The second catheter that broke was from the same lot number.Both catheters broke into two pieces and were fully removed from the patient.As reported, no section of the device was retained by the patient.There were no adverse consequences to the patient as a result of this reported issue.
Additional Manufacturer Narrative
Outcomes and adverse event: correction: intervention was not required.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the open-end ureteral catheter was not returned for evaluation and no photographs were provided.A physical examination could not be performed on the actual device.A review of complaint history, the device history record, manufacturing instructions, and quality control data was performed.The device history record was reviewed and no non-conformances were identified during the manufacturing process that would cause or contribute to the reported failure mode.A review of complaint history revealed there are no other complaints associated with the complaint device lot number 8339298.Without the device and based on the provided information a likely cause for the reported issue could not be established.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: OPEN-END 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: 7406163
• Report Number: 1820334-2018-00946
• Device Sequence Number: 1146870
• Product Code: GBL
• UDI-Device Identifier: 00827002142749
• UDI-Public: (01)00827002142749(17)201101(10)8339298
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2018

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 Catalogue Number: 020015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 05/14/2018; 05/23/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 05/15/2018; 05/29/2018
• 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