MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET; FAD STENT, URETERAL

Catalog Number RMS-060026-R

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Dr (b)(6) installed a resonance double j 6 x 26 on a patient on (b)(6), 2023.Today (b)(6), dr (b)(6) communicated that the installed double j has moved hence migrated to the proximal ureter of the patient which leads to a second procedure for replacement.Per email received on 16jan2024: stent migrated up the ureter.(b)(6) (b)(6) 2024.Patient outcome: yes: stent replacement.Patient/event info - notes: the following information has been received via email on 15jan2024.(b)(6) 15jan2024 did anything have to be removed from the patient? if yes, please specify: yes the stent migrated.What device was removed? the stent what part of the body the device was removed from? proximal ureter why was the stent removed? it migrated.If the stent was removed what was used to complete the procedure? no did the patient require any additional procedures as a result of this event? yes, another stent had to be placed.What intervention (if any) was required? n/a was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a.The following information has been requested via email on 15jan2024.(b)(6) (b)(6)2024 1.Customer/facility name/id: 2.Contact at facility and contact info: 3.Will the facility be reporting this to a government agency (fda, competent authority, etc.) 4.Is an acknowledgment letter (formal notification of the complaint being received) required? 5.To whom should the no charge replacement be sent to? is a po# required? 6.Gpn: 7.Lot: 8.Quantity and unit (ea/bx) a.Reported, used: b.Reported, prior to use: c.Reported, unused: 9.Will the product be returned? a.If yes a return label will be provided.10.Usage of product (please select only one below): a.Initial use of device b.Reuse of device c.Unknown 11.Was product reprocessed for reuse prior to occurrence? 12.Description of event: 13.Can you provide any patient information (age, weight, gender, pre-existing conditions)? 14.What type of procedure was being performed? 15.Did the event result in a death? 16.Did any unintended section of the device remain inside the patient¿s body? a.If yes, please describe.17.Was the patient hospitalized or was there prolonged hospitalization? 18.Did the patient require any additional procedures due to this occurrence? 19.Did the product cause or contribute to the need for additional procedures? a.If yes, please specify additional procedures and provide details.20.Has the complainant reported any adverse effects on the patient due to this occurrence? 21.Has the complainant reported that the product caused or contributed to the adverse effects? a.Please specify adverse effects and provide details.22.How was the procedure able to be completed? 23.Are any images available for review? 24.What was the target location for the stent? 25.What was the length of the indwell time? 26.What disease mode was the physician trying to treat? 27.What type and size wire guide was used with the device? 28.Did the device come with a pigtail straightener? a.If yes, was the pigtail straightener used? 29.Did the user attempt to attach the stent to the inserter before or after wire guide insertion? 30.Did the user attempt to attach the tapered end of the stent to the inserter? 31.Was this device assembled outside of the body? 32.Was the stent stored in strong light (e.G.In a pyxis maching) or in direct sunlight? 33.Was there difficulty advancing the stent to the target location? 34.How long was the stent in-dwelling? 35.What was used to remove the stent? 36.How often was the stent checked during the in-dwelling time? a.What method was used? 37.Was the patient using calcium supplementation? 38.Was force required to remove the stent? 39.Was encrustation evident on the stent? 40.What is the source of the extrinsic compression? 41.If caused by a tumor, what is the tumor type? a.What is the stage of the tumor? the following information has been received via email on 16jan2024.(b)(6) (b)(6)2024 10.Usage of product (please select only one below): a.Initial use of device initial use 11.Was product reprocessed for reuse prior to occurrence? no 12.Description of event: stent migrated up the ureter 14.What type of procedure was being performed? patient stenting 15.Did the event result in a death? no 16.Did any unintended section of the device remain inside the patient¿s body? no a.If yes, please describe.17.Was the patient hospitalized or was there prolonged hospitalization? no 18.Did the patient require any additional procedures due to this occurrence? yes: stent replacement 19.Did the product cause or contribute to the need for additional procedures? no a.If yes, please specify additional procedures and provide details.20.Has the complainant reported any adverse effects on the patient due to this occurrence? no 21.Has the complainant reported that the product caused or contributed to the adverse effects? no a.Please specify adverse effects and provide details.22.How was the procedure able to be completed? migration of device happened after procedure completion 24.What was the target location for the stent? ureter 25.What was the length of the indwell time? about a month 26.What disease mode was the physician trying to treat? extrinsic compression 27.What type and size wire guide was used with the device? device introduced through a coaxial system not over a wire 28.Did the device come with a pigtail straightener? yes a.If yes, was the pigtail straightener used? yes 29.Did the user attempt to attach the stent to the inserter before or after wire guide insertion? n/a 30.Did the user attempt to attach the tapered end of the stent to the inserter? n/a 31.Was this device assembled outside of the body? n/a 32.Was the stent stored in strong light (e.G.In a pyxis maching) or in direct sunlight? no 33.Was there difficulty advancing the stent to the target location? no 34.How long was the stent in-dwelling? about a month 35.What was used to remove the stent? stent extractor 36.How often was the stent checked during the in-dwelling time? once a.What method was used? cystoscope 37.Was the patient using calcium supplementation? n/a 38.Was force required to remove the stent? no 39.Was encrustation evident on the stent? no.The following information has been received via email on 22jan2024.(b)(6) (b)(6) 2024 question 6 : le 6 x 26 qui a été installé porte le numéro rms-060026-r (g34111).Il a été commandé via la commande bdc377586 question 7 : le lot c2090713 question 9 : il sera probablement possible de faire stériliser le double j non fonctionnel pour vous l'envoyer.D'ici 1 mois il sera changé.The device will be returned at the time of the stent exchange within a month, question 23 : oui j'ai deux images a t'envoyer.Ce sont des images du scan post installation.Post installation image will be provided question 40 : sarcome pelvien pelvic sarcoma question 41 : c'est un sarcome localement envahissant invasive.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 18666219
• MDR Text Key: 334832706
• Report Number: 3001845648-2024-00041
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RMS-060026-R
• Device Lot Number: C2090713
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/08/2024
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention