MAUDE Adverse Event Report: COOK INC ROUND TIP URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Catalog Number 024103-S1

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/02/2017

Event Type  Injury  

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 Description

The user facility reported during an ureteroscopy procedure, after using the 3fr ureteral catheter in the channel of the cystoscope, little bits of the catheter were coming off in the patient¿s bladder.Some of the pieces of the catheter were retrieved.However, some of the pieces of the device remained inside the patient¿s body.As reported, the patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse consequences as a result of the reported device issue.

Manufacturer Narrative

The patient didn¿t require any further follow up.It is believed that the fragments from the stent that were in the bladder were flushed through and removed at the time of the procedure.There have been no further complications or adverse effects with this patient.There have also been no other reports of any other 3f ureteric stents that have broken down.Investigation ¿ evaluation: a review of device history record, complaint history, specifications and visual inspection of the complaint device was conducted on the returned product during the investigation.The round tip ureteral catheter was returned for evaluation.One open package labeled rpn 020013-s1 and lot number 7634637 was received.The 3fr catheter was received with the stylet inside.The distal tip was intact and the catheter measured 125 cm in length.Scrape marks were observed on the outer surface of the catheter starting at the first ink band and continuing and ending at the 6cm ink band.A sliver of green and black material was returned in a specimen cup with a clear liquid solution.Based on the evidence presented by the sample and the physical analysis, this device has been damaged by an instrument of unknown origin.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device history record for the product/lot was reviewed and no non-conformances were identified during the manufacturing process.A review of complaint history revealed there are no other complaints associated with lot number 7634637.Based on the provided information and results of device investigation, the definitive root cause is product use or handling related.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.

• Brand Name: ROUND TIP URETERAL CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6864621
• MDR Text Key: 86118733
• Report Number: 1820334-2017-02782
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002158214
• UDI-Public: (01)00827002158214(17)200130(10)7634367
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 024103-S1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention