MAUDE Adverse Event Report: COOK INC UNIVERSA FIRM URETERAL STENT SET; FAD STENT, URETERAL

Model Number G49877

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510k # k161236.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 ureteric stenting on a (b)(6)-year old male patient using a universa firm ureteral stent set, it was found after the first placement attempt that the proximal coil of the stent would not coil.The physician then attempted to place the stent two more times without successful coiling.The stent was then removed with rigid cystoscopy forceps, when it was discovered that the stent was not coiling.After 15 minutes out of dwelling the stent returned to its curled position.The procedure was completed with a different branded stent.No adverse effects to the patient have been reported due to this event.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Corrected information: b1, h1 additional information: d10 b1: there was no reportable product problem or serious injury associated with this complaint.D10: the complaint device was returned.One used device and 7 unused devices were returned for investigation.H1.There was no reportable malfunction of the complaint device.There is no precedent setting event to consider the complaint a reportable event.Investigation-evaluation a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, quality controls, manufacturing instructions, the instructions for use, and specifications.One used and 7 unused devices were returned for investigation.The returned packaging confirms the reported complaint device lot number.Visual examination confirmed that the used device was a ufsml-600-aq 6fr 22-32cm multi coil stent.The width of both the distal and proximal coil measured 19mm.One of the unopen devices was used for investigation.The coil width on the unused stent was 18mm.Function test was performed by wiring the used stent with a.038¿ wire guide.The wire was pulled out and the pigtail returned to the coiled position measuring 19mm wide.The unused stent coil width measured 18mm on both coils.The stent was wired using the returned set wire guide.After the wire was removed, the pigtail returned to the coiled position measuring 20mm wide.Both the used and unused stents spontaneously returned to the coiled position when wire guide was removed relaxing the coil width 1-2mm outside the original specified tolerance of 13-18mm as listed on stent drawing.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot 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: 4.Watch for the distal end of the stent at the ureterovesical junction.At that point, halt advancement of the stent.As an assistant removes the wire guide, hold the stent in position with the positioner.The stent pigtail will form spontaneously.Carefully remove the positioner from the cystoscope.The customer returned a used stent which was wired using a 0.038¿ wire guide to attempt to replicate the reported failure mode.When the wire guide was removed the stent returned to its original shape spontaneously.The customer also returned 7 unused stents, and one of the unused stents was wired and returned to its original shape spontaneously in a similar manner the used stent.As the customers difficulty was unable to be repeated a cause could not be established from the returned devices.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

There is no new patient or event information to report.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8935999
• MDR Text Key: 155697196
• Report Number: 1820334-2019-02132
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002498778
• UDI-Public: (01)00827002498778(17)191122(10)NS7465397
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2019
• Device Model Number: G49877
• Device Catalogue Number: UFH-600
• Device Lot Number: NS7465397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEMI-RIGID URS, OPEN-END URETERAL CATHETER; SEMI-RIGID URS, OPEN-END URETERAL CATHETER
• Patient Age: 27 YR