MAUDE Adverse Event Report: COOK INC OPEN-END FLEXI-TIP URETERAL CATHETER; KOD CATHETER, UROLOGICAL

Model Number	G14521
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510k #: k171662.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, at the beginning of a ureteroscopy procedure using a open-end flexi-tip ureteral catheter, the proximal flexi-tip broke off.When the physician began to put the catheter over the wire guide, the tip broke.Another device was used to completed the procedure without issue.No section of the device remained inside of the patient.The initial reporter stated that no patient contact was made.No adverse effects to the patient have been reported.
Event or Problem Description
No additional patient or event information since the last report was submitted.
Additional Manufacturer Narrative
Investigation - evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, manufacturing instructions, specifications, and quality control data.The complainant returned one open package containing an open-end flexi-tip ureteral catheter for investigation.Visual examination confirmed a catheter was returned in prior to use condition.The length of the catheter was 69cm.The catheter was returned in two pieces.The flexible tip was separated from the distal tip, and the point of separation occurred above the first ink band.The length of the flexible tip measured 8mm and was within specification tolerance of 6mm-9mm.The point of separation has occurred where the two pieces of material are bonded together.A review of the device history record found no non-conformances related to the reported failure mode.Eight catheters from this lot were test pulled and part of the quality control procedure and all passed minimum test pull criteria of 3.5lbs.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The customer returned catheter was observed to have separated at the glue bond of the flexible tip of the catheter.A review of the dmr identified controls for the reported failure mode including pull testing samples from the lot.A review of the dhr did not identify any related anomalies and there have been no other complaints reported for the lot.The cause of the separation was not established.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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 FLEXI-TIP URETERAL CATHETER
• Common Device Name: KOD CATHETER, UROLOGICAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9564123
• Report Number: 1820334-2020-00084
• Device Sequence Number: 2223974
• Product Code: KOD
• UDI-Device Identifier: 00827002145214
• UDI-Public: (01)00827002145214(17)221023(10)10102544
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: 10/23/2022
• Device Model Number: G14521
• Device Catalogue Number: 021305
• Device Lot Number: 10102544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RIGID CYSTOSCOPE