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

Model Number	G14818
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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 during a retrograde pyelogram for ureteral stent placement using an open-end ureteral catheter, the device sheared off inside the patient.The device fragments were retrieved using a grasper.No device fragments remained inside the patient.It was reported that the patient did not experience any adverse effects due to this event.Additional information has been requested.At this time, no further details have been provided.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.It was reported on 24mar2020, of an event involving a open end ureteral catheter (rpn: 020013).During a retrograde pyelogram for ureteral stent placement, an open-end ureteral catheter was used.Reportedly, the device sheared off inside of the patient.No pieces of the device were left inside the patient as the separated parts were retrieved with graspers.There was no harm to the patient as a result of the event.The complaint device was returned for a manufacturer's evaluation.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 , specifications, and quality control data.The complainant returned one 3 french open-end ureteral catheter for investigation.Visual examination confirmed a catheter was returned in used condition.The catheter length measured 72.2cm.The damage to the catheter was observed under magnification.The catheter was kinked 6cm and again 10cm from the distal tip, and there were several bends noted along the catheter length.The material was weak 2cm from the distal tip, and the catheter has an angle cut 6cm from the distal tip.Scrapes were visible on the catheter beginning at the 8cm ink band, length of scrape mark is 24cm.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.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 separated pieces that were reported were not returned.The damage to the catheter appears to have come from an instrument of unknown origin during the procedure.The damage is consistent with clinical use.There is no indication that a design process or related failure mode contributed to this event.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.
Event or Problem Description
Additional information provided on 01apr2020: a standard double j indwelling ureteral stent was placed as planned.

• Brand Name: OPEN-END URETERAL CATHETER
• Common Device Name: KOD CATHETER, UROLOGICAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9928108
• Report Number: 1820334-2020-00752
• Device Sequence Number: 16850791
• Product Code: KOD
• UDI-Device Identifier: 00827002148185
• UDI-Public: (01)00827002148185(17)221213(10)10211619
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K171662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

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: 12/13/2022
• Device Model Number: G14818
• Device Catalogue Number: 020013
• Device Lot Number: 10211619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 04/08/2020
• 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: WOLF RIGHT ANGLE SCOPE
• Patient Age: 5 YR
• Patient Weight: 19