MAUDE Adverse Event Report: COOK INC C-FLEX DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Model Number G14637

Device Problems Material Separation (1562); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k #: k162104.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 cystoscopy procedure to remove a stent, which is included in the c-flex double pigtail ureteral stent set, the stent was torn.The device was handled with accustomed forceps during removal and it tore.The individual torn off pieces were able to be retrieved from the ureter with no harm to the patient.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

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, the instructions for use, quality control data, and specifications.One device was returned for investigation.The packaging/label was not returned with the device.Inspection of the returned device confirmed that only the stent was returned.The stent was returned separated into 7 segments.One segment included a full coil that measured 6 cm from the end of the could to the point of separation.The coil relaxed out of specified tolerance.The tip of the coil was smashed and split, which measured 2 mm long.The second segment measured 1.5 cm long.Separation occurred at the side port.The third segment measured 2 cm.Separation at both ends occurred at the side ports.The fourth segment measured 2.5 cm.The point of separation on one end occurred at the side port.The fifth segment measured 2 cm.Separation at both ends occurred at the side ports.The sixth segment measured 2.2 cm and included the ink band.The point of separation was located at the side ports on both ends.Grasper marks were noted below the ink band.The seventh segment was a partial coil and measured 2.2 cm.The first side port was split on both sides of the hole.A review of the device history record (dhr) for the stent set lot number and the stent component lot number were reviewed and found no non-conformances.A review of complaint history records shows no other complaints associated with the complaint device lot.As there are no non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: the endoscopic stent placement section includes the following: note: if necessary, final adjustment can be made with endoscopic forceps.The stent may be removed easily by gentle withdrawal traction using endoscopic forceps.Precautions in the ifu include: manipulation of the wire guide requires appropriate imaging control.Use caution not to force or over manipulate the wire guide when gaining access.When using a wire guide through a metal cannula/ needle, use caution as damage may occur to the outer coating.When exchanging or withdrawing an instrument over the wire guide, secure and maintain the wire guide in place under fluoroscopy in order to avoid unexpected wire guide displacement.These wire guides are intended for ptca use.Complications of ureteral stent placement are documented.Use of this device should be based upon consideration of risk-benefit factors as they apply to each patient.Informed consent should be obtained to maximize patient compliance with follow-up procedures.Endo-sof stents must not remain indwelling more than twelve months.Polyurethane, c-flex, sof-flex and lse sof-flex, stents must not remain indwelling more than six months.If patient status permits, the stent may be replaced with a new stent.These stents are not intended as permanent indwelling devices.Do not force components during removal r replacement.Carefully remove the components if any resistance is encountered.A pregnant patient must be more closely monitored for possible stent encrustation due to calcium supplements.Improper handling can seriously weaken the stent.Acute bending or overstressing during placement may result in subsequent separation of the stent at the point of stress after prolonged indwelling period.Angulation of the wire guide or stent should be avoided.Use of a 0-degree scope lens is recommended.Scopes larger than 21.0 french are suggested.Individual variations of interaction between stents and the urinary system unpredictable.Periodic evaluation via cystoscopic, radiographic, or ultrasonic means is suggested.The stent must be replaced if encrustation hampers drainage.The returned stent was separated into 7 segments of various lengths between 1.5cm and 6cm.The separated segments showed no evidence of manufacturing anomalies.The complaint was confirmed based on customer testimony and analysis of the returned device.The cause of the complaint could not be established.It is possible procedural difficulties (resistance with advancement and/or withdrawal) could have contributed to the complaint.The instruction for use precautions against forcing components during removal or replacement and to carefully remove the components if any resistance is encountered.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.We will continue our monitoring of similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional patient or event information has been received since the last report was submitted on 02oct2019.

• Brand Name: C-FLEX DOUBLE PIGTAIL URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9145623
• MDR Text Key: 176591170
• Report Number: 1820334-2019-02511
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002146372
• UDI-Public: (01)00827002146372(17)190720(10)7134970
• 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: 11/26/2019

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: 07/20/2019
• Device Model Number: G14637
• Device Catalogue Number: 036310
• Device Lot Number: 7134970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 11/22/2019
• Supplement Dates FDA Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS ENDOSCOPE AND FORCEPS
• Patient Age: 3 MO