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

Model Number G14787

Device Problem Material Separation (1562)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

Pma/510k # k162104.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

During an unspecified procedure involving a patient of unknown gender and age, a portion of the wire guide included in a c-flex double pigtail ureteral stent set separated within the patient.As the physician began placement of the stent, difficulties were experienced, and the wire guide bent.As the complaint device was pulled back, a portion broke off.Due to inflammation, the medical staff opted to leave the separated portion in the patient.According to the initial reporter, the patient is scheduled to return for another procedure unrelated to this incident, and it is planned to remove the separated portion of the wire guide at that time.It is unknown if the product is available for return.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: e4.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of device history record, the instructions for use, quality control data, and specifications.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.Inspection of the returned device noted the device was returned in used condition and damaged.A severe kink 2.5 cm from the proximal ink band was located at a sideport.The proximal coil was stretched and relaxed out of shape.There are also two sideports on the stent body, below the ink band, that were stretched.The distal coil was severed 2.5 cm from the distal ink band.The point of separation on the distal coil had an angular cut and was pulled to separation.The severed section was not returned.The remaining section of the coil was relaxed and had three sideports, one of which was stretch.The remainder of the sideports were undamaged.A review of the device history record found the following non-conformances related to the reported failure mode.Qty nc code nc description 1 295 foreign matter loose.The work orders for the stent component lots (ic9081894/ic9081898/ic9081900) was reviewed and following non conformances had been recorded qty nc code nc description 16 958 tip/tape, inadequate, incomplete or missing 1 530 sideport, incorrect location or size or pattern or quantity or angle 23 117 length incorrect cook has concluded these non conformances are unlikely to be related to the failure of the stent.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: - 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 f 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.-these stents are not intended as permanent indwelling devices.- do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.- 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.The cause of the complaint could not be established, based on a clinical review of the complaint the most likely causes of the event include patient anatomy challenges (patient muscle tone and contraction), disease state (impacted upj stone) and procedural difficulties (resistance with advancement and withdrawal).The returned device had a severe kink, the proximal coil was stretched (the side ports on this coil were all out of shape) and relaxed so it was no longer it`s original shape.The distal coil was severed with a section missing and one of the side ports on the distal coil appeared stretched.The risk was assessed with qera 1150 rev 003 which concluded no additional action is required.Monitoring is in place should additional complaints of the same failure mode be reported.Per the quality engineering risk assessment, no further action is warranted.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

No new patient or event information to report.

Event Description

It was initially reported that a portion of a wire guide included in a c-flex double pigtail ureteral stent set separated within the patient.Additional information was received on 31jul2019: during a cystoscopy, ureteroscopy, laser lithotripsy, and stent placement for the treatment of an impacted ureteropelvic junction stone, 3 cm of the distal end of the 3.7 x 16 cm stent broke off.A similar stent was placed.It was reported that the fragment is being monitored and remains in the renal pelvis of the patient.Additional information was received on 16aug2019: the separated fragment of the stent has not yet been retrieved.The reporter states that the fragment retrieval will not require an additional treatment because another ureteroscopy was already planned due to the large stone burden of the patient.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.D11:0.025 in ptfe guidewire, open-end ureteral catheter.H3: device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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.

• 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: 8840874
• MDR Text Key: 152626463
• Report Number: 1820334-2019-01853
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002147874
• UDI-Public: (01)00827002147874(17)210918(10)9172685
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2021
• Device Model Number: G14787
• Device Catalogue Number: 036316
• Device Lot Number: 9172685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Date Manufacturer Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR
• Patient Weight: 17