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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that at the end of a ureterorenoscopy procedure, when the physician removed the catheter, it was noted the catheter had a piece of the length ¿cut off¿ and was indwell in the ureteral of the patient.A ureteroscope and forceps were used to remove the fragment.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation a review of the dimensional verification, documentation, functional test and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported: the device was returned in two segments.Catheter separated 3cm from the distal tip; separation occurred at the third ink band within the first sideport.Visual appearance of point of separation was ragged and showed signs of being cut and pulled to separation.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, and the results of our investigation, the device was most likely cut during use.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
It was reported that at the end of a ureterorenoscopy procedure, when the physician removed the catheter, it was noted the catheter had a piece of the length ¿cut off¿ and was indwell in the ureteral of the patient.A ureterosope and forceps were used to remove the fragment.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: ROUND 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: 6022104
• Report Number: 1820334-2016-01097
• Device Sequence Number: 13589299
• Product Code: GBL
• UDI-Device Identifier: 00827002140431
• UDI-Public: (01)00827002140431(17)190616(10)7048798
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 024104
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2016
• Supplement Report FDA Received Date: 01/10/2017
• 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
• Patient Age: 40 YR