MAUDE Adverse Event Report: COOK IRELAND LTD ZIMMON PANCREATIC STENT; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G22980
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Additional patient information received on customer complaint reporting form: please indicate where the device was stored prior to use.This product was located in the ercp room prior to use.What is the reorder number, outer diameter and length of the wire guide that was used with this device in this procedure?* visiglide 2 guidewire - outer diameter 0.025in / length 450cm / tip shape angled / first use were previous procedures i.E.Sphincterotomy etc.Carried out prior to placing the device over the particular wire guide? if yes please indicate the procedure performed.They performed est procedure on the patient before place the stent.Was the wire guide inspected for damage prior to use?* yes, it was.Was the device at the centre of the complaint inspected for damage prior to use? yes, it was.Did the patient involved exhibit altered anatomy or tortuous anatomy? no.If not with the device in question, how was the procedure finished?* they finished procedure after using the another spsof-5-5.Had a sphincterotomy been performed prior to this occurrence? yes, they had.What is the endoscope manufacturer, the model number and working channel size that was used for the procedure? olympus tjf260v, 4.2mm.Does your medical facility have a service/maintenance schedule associated with its endoscopes? unknown.Please indicate the location in the body where the stent device was to be placed.I.E.Biliary duct, pancreatic duct, other.The pancreatic duct.Was resistance encountered when advancing the wire guide to the target location?* no, it wasn't.Was the stricture dilated prior to placing the device?* if so, please indicate what device(s) were used.No.Was resistance encountered when advancing the introduction system in place to the target location?* yes, it was.Was resistance encountered when advancing the stent through the obstructed area?* n/a (mark n/a if device was not used on any patient) after placement, was stent position verified? if yes, please describe how.After placed the wire guide over the stricture site, they tried to insert the stent along the wire guide, but the stent did not pass through the stricture site.Please estimate/indicate the amount of time the stent was in place dwelling prior to this occurrence.They tried for about 10 minutes to place the stent.Did any section of the device detach inside the endoscope or patient? no.Additional information provided 19sep2018: can you also ask the customer which end went into the body first please? ¿they've been using it a lot since a long time ago.They always use stent first in a tapered direction.¿ additional information received 21sep2018: a piece of the stent including the flap was noted to be missing upon return.How did the piece become detached and was it thrown away? ¿i went to see the customer.I asked the customer about your question, but the customer replied that he did not know well.¿ lab evaluation: 1 x spsof-5-5 of lot c1462265 was returned to cirl for a lab evaluation.During the lab evaluation a kink was noted at the second porthole on the pigtail end and a 0.035¿ wireguide would not pass the kink when it was passed through the stent.There was also damage noted at the flap end: there were marks which are consistent with forceps which would have been used to remove the stent, the flap was broken off the stent and noted to be missing/ not returned, the missing flap and the deep indentations from the forceps would suggest that the stent got stuck on the stricture.It should be noted that the customer stated that there was difficulty passing the introducer system passed the stricture and a 0.025¿ wireguide was used, however a 0.035¿ wireguide is recommended for use with this device as per the product label.It is possible that the smaller wireguide may have contributed to the inability to pass the stricture.The customer complaint is confirmed as the stent was found to be broken ( flap missing) during the laboratory evaluation, it is likely that the stent broke during the attempted removal after the stent could not pass a tight stricture.Documents review: a review of the manufacturing records for the spsof-5-5 pancreatic stent device of lot c1462265 did not reveal any discrepancies that could have contributed to this event.There is no evidence to suggest that this complaint affects the entire lot c1462265, upon review of complaints history this failure mode has not occurred previously with lot c1462265.Ifu review: it may be noted that according to the instructions for use, ifu0055-3, the user is instructed to: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use¿.It should be noted that according to the ifu (ifu0055-3) precautions section the customer is instructed that ¿a complete diagnostic evaluation must be performed, prior to use, to determine proper stent size.¿ it should also be noted that according to the ifu (ifu0055-3) the user is instructed that for 7fr stents and smaller " introduce stent tapered tip first, and pigtail straightener* onto pre-positioned wireguide".Prd/ fqc review: prior to distribution, all spsof devices are subjected to 100% inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.There is also a visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc.Root cause: the most probable root cause is that patient anatomy prevented the stent from passing the stricture and the stent flap was broken off during removal of the device.Given the complaint description states that the stent could not pass the stricture it is likely that the stricture was too tight which may have contributed to the stent flap breaking off during the attempted removal.However as the conditions of use could not be replicated in the lab evaluation due to a variety of clinical conditions such as patient anatomy, a root cause could not be determined for the customer complaint.Other possible root causes could be attributed to the 0.025¿ wireguide reducing the push ability of the stent, this products carries a label which indicates the use of a 0.035¿ wireguide, and also that the stent size was incorrectly selected and was unable to pass the stricture.However, as there is very limited information available a definitive root cause for the customer complaint could not be determined.The complaint is confirmed as the stent was found to be broken during the lab evaluation.Summary: complaints of this nature will continue to be monitored for potential emerging trends.The complaint is confirmed as the stent was found to be broken during the lab evaluation.
Event or Problem Description
The device was evaluated on the (b)(6) 2018 confirming the stent flaps were missing, this complaint is being reported under the fda mdr malfunction of "stent fracture" they tried to put the spsof-5-5 in an pancreatic duct, but the stent could not pass through the stricture in the pancreatic duct.

• Brand Name: ZIMMON PANCREATIC STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7904933
• Report Number: 3001845648-2018-00446
• Device Sequence Number: 16591158
• Product Code: FGE
• UDI-Device Identifier: 00827002229808
• UDI-Public: (01)00827002229808(17)210310(10)C1462265
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K900923
• 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
• Report Date (Section B): 09/25/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2021
• Device Model Number: G22980
• Device Catalogue Number: SPSOF-5-5
• Device Lot Number: C1462265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/25/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 55