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

Model Number	G34109
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
510 (k) number: k063742.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As reported to customer relations, "a piece of stent sheathing broke off during a stent replacement procedure.The piece was completely removed- no injury." info provided as well on customer's email train: one of our urologists had a piece of the sheathing break off during a stent placement in the operating room (or).The foreign body was removed in its entirety.The patient is fine.
Additional Manufacturer Narrative
510 (k) number: k063742 cook (b)(4) ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031 importer site contact and address: (b)(6).Cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113 device evaluation: as the rms-060022-r of lot number c1435503 was not returned to cirl for evaluation and the additional information was never made available a limited documentation based investigation was completed.Lab evaluation: 1 x rms-060022-r of lot number c1435503 was not returned to cirl for an evaluation therefore a documentation based investigation was completed.The complaint is confirmed based on customer¿s testimony.Root cause: a possible root cause could be attributed to excess pressure being placed on the catheter sheath during stent placement, however as the device was not returned and there was very limited information available from the user it is not possible to conclusively determine the root cause of this complaint.Documents review: a review of the manufacturing records for the device of lot # c1435503 did not reveal any discrepancy related to the complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1435503; upon review of complaints this failure mode has occurred previously with this lot # c1435503, however it is likely that both complaints are attributed to the same event and involve the same device as the event date and description and lot number are identical with one complaint (b)(4) originating from a report pulled from the competent authority complaint log and this complaint (b)(4) originating from a customer who stated that they reported this event to the competent authority.However erring on the side of caution both complaints will be captured and investigated.Components supplied by external suppliers are subject to incoming inspection and were accepted into cook ireland.Manufacturing team member (mtm) is to visually ¿check that the tubing is uniform along its length and free from kinks or debris".It should be noted that two units of clear fep tubing with fett tip were scrapped during manufacturing due to damage, however it is unlikely that this scrap contributed to this event as all units are 100% inspected during catheter assembly - ¿inspect tubing for dents and kinks¿ there is also inspection of the final product which instructs the mtm to ¿check sheath is clean and free from grease or contamination and not kinked along its length.¿ there is also a visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc - "complete a 100% visual inspection of the packaged unit (tyvek pouched) while held at a comfortable arm¿s length from the unaided eye at normal lighting conditions." ifu review: it should be noted that according to the instructions for use, ifu0020-15, the user is instructed the following: ¿do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.¿ summary: complaints of this nature will continue to be monitored for potential emerging trends.The complaint is confirmed based on customer testimony.
Event or Problem Description
As reported to customer relations, "a piece of stent sheathing broke off during a stent replacement procedure.The piece was completely removed- no injury." info provided as well on customer's email train: one of our urologists had a piece of the sheathing break off during a stent placement in the or.The foreign body was removed in its entirety.The patient is fine.

• Brand Name: RESONANCE STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7955552
• Report Number: 3001845648-2018-00479
• Device Sequence Number: 1514025
• Product Code: FAD
• UDI-Device Identifier: 10827002341095
• UDI-Public: (01)10827002341095(17)201220(10)C1435503
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K063742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/20/2020
• Device Model Number: G34109
• Device Catalogue Number: RMS-060022-R
• Device Lot Number: C1435503
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/13/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention