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

Catalog Number 020013

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510k # ¿ pre-amendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported, during a retrograde pyelogram / catheter insertion procedure that the open-end ureteral catheter was inserted for use, and part of ureteral catheter disintegrated and was spotted in left ureteral orifice (uo).This part was then retrieved from the patient.The case, as reported, was a 3 stage surgery that started off with a rigid cystoscopy first.A ureteric catheter was inserted by the doctor retrograde for a pyelogram, soon after there was an unidentified green string-like object with black spots dangling from the uo spotted on the camera screen.The doctor and her assistant were notified and asked for a grasper to retrieve the object and it was removed.Upon taking out the ureteral catheter it was found that part of the outer side of the ureteral catheter had disintegrated.Surgeons did a visual inspection with rigid cystoscope.It was further reported that the patient's anatomy was not tortuous or calcified.It was further clarified that the insertion was easy and while doing the pyelogram and pushing the sheath up it was noted that the "sheath" was coming off.Once the catheter was removed the dislodged piece was removed with forceps.It was further states that the ureteric orifice was looking traumatized and there was a little more hematuria than normal for a pyeloplasty.The customer stated that the patient was otherwise well.No report of any serious injury.

Manufacturer Narrative

Investigation evaluation: a visual examination of the returned device was performed.A review of complaint history, the device history record, manufacturing instructions, and quality control data was also conducted.One open package labeled rpn 020013 and label lot number 8513662 was received.In addition, a specimen cup containing material shavings was returned.Dimensional verification of the device determined the length of catheter measured 69.7cm.Under magnification, the contents of the specimen cup were determined to be two green shavings from the returned catheter.Scrape marks were observed on the catheter starting at 6.7cm from the distal tip, continuing down the catheter and stopping 20.5cm from the distal tip.The returned specimens did not display any signs of manufacturing anomalies.This device has been scraped/damaged during use by an instrument of undetermined origin.On the 21jun2018, it was confirmed that all of the products from lot 8513662 had shipped to the australian distribution center and all had been distributed to australian customers.The device history record for the product/lot was reviewed and found there no non-conformances during the manufacturing process.A review of the complaints database found no other complaints associated with the complaint device lot number 8513662.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.This device has been scraped/damaged during use by an instrument of undetermined origin.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.

Event Description

It was reported, during a retrograde pyelogram / catheter insertion procedure that the open-end ureteral catheter was inserted for use, and part of ureteral catheter disintegrated and was spotted in left ureteral orifice (uo).This part was then retrieved from the patient.The case, as reported, was a 3 stage surgery that started off with a rigid cystoscopy first.A ureteric catheter was inserted by the doctor retrograde for a pyelogram, soon after there was an unidentified green string-like object with black spots dangling from the uo spotted on the camera screen.The doctor and her assistant were notified and asked for a grasper to retrieve the object and it was removed.Upon taking out the ureteral catheter it was found that part of the outer side of the ureteral catheter had disintegrated.Surgeons did a visual inspection with rigid cystoscope.It was further reported that the patient's anatomy was not tortuous or calcified.It was further clarified that the insertion was easy and while doing the pyelogram and pushing the sheath up it was noted tha the "sheath" was coming off.Once the catheter was removed the dislodged piece was removed with forceps.It wa further states that the ureteric orifice was looking traumatized and there was a little more hematuria than normal for a pyeloplasty.The customer stated that the patient was otherwise well.No report of any serious injury.

• Brand Name: OPEN-END URETERAL CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7627732
• MDR Text Key: 112454778
• Report Number: 1820334-2018-01692
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002148185
• UDI-Public: (01)00827002148185(17)210116(10)8513662
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/13/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2021
• Device Catalogue Number: 020013
• Device Lot Number: 8513662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 07/12/2018
• Supplement Dates FDA Received: 07/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CYSTOSCOPE
• Patient Age: 8 YR
• Patient Weight: 30