MAUDE Adverse Event Report: COOK IRELAND LTD SOLUS BILIARY STENT AND INTRODUCER SET; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G25672
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Complaint called in by dm on 10mar2020--did 10mar2020.As reported to customer relations: "customer went to deploy stent, and guiding catheter stretched and made deployment impossible.The white hub came off the catheter when they tried to deploy.Customer had to remove all of product/delivery system; they completed the procedure somehow, but unknown with what sort of device.No add'l procedures required, no adverse effects experienced by patient, nothing remaining in patient, no prolonged hospitalization.".
Event or Problem Description
As reported to customer relations: "customer went to deploy stent, and guiding catheter stretched and made deployment impossible.The white hub came off the catheter when they tried to deploy.Customer had to remove all of product/delivery system; they completed the procedure somehow, but unknown with what sort of device.No additional procedures required, no adverse effects experienced by patient, nothing remaining in patient, no prolonged hospitalization." did any unintended section of the device remain inside the patient¿s body? no if yes, please describe.2.Was the patient hospitalized or was there prolonged hospitalization due to the event? no if yes, please describe.3.Did the patient require any additional procedures due to this occurrence? no if yes, please describe.4.Did the product cause or contribute to the need for additional procedures? no if yes, please specify additional procedures and provide details.5.Has the complainant reported any adverse effects on the patient due to this occurrence? no.6.Has the complainant reported that the product caused or contributed to the adverse effects? no.Please specify adverse effects and provide details.
Additional Manufacturer Narrative
Device evaluation: 1 x zss-10-5-rb of lot# c1697352 was returned to cirl for evaluation opened with its original packaging.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on (b)(6) 2020.The black guiding catheter was returned loaded on the purple pushing catheter.White hubs were present as expected.The purple pushing catheter is kinked/ damaged at approx.39cm from the white hub.The black guiding catheter is also damaged at approx.25-30cm from hub.Stent was returned with no visual damage.A 0.035¿ wire guide would not pass damage on the catheters.Black guiding catheter moves freely through purple pushing catheter.Stent was deployed using black guiding catheter, wire passed through the distal end of the black guiding catheter, stent allowed catheter to pass.Image review: n/a.Document review including ifu review: prior to distribution zss-10-5-rb devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for zss-10-5-rb of lot number c1697352 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1697352.It should be noted that the instructions for use (ifu0100-1) states the following: ¿if package is opened or damaged when received, do not use.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 was noted in the lab evaluation that that the distal end of the guiding catheter can move freely through the stent allowing the deployment of the stent.This is an indication that the clearance between it and the stent was not responsible for the difficulty in withdrawing the catheter.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.According to additional information received ¿what caused the damage to the pushing and guiding catheters, and was there resistance during advancement? unknown.It would not advance.¿ a possible root cause for issues experienced could be attributed to the stent becoming caught on the elevator of the scope.Both the proximal and distal marker bands on the stent appear to have moved slightly in the same direction which is an indication that the stent was forced through an opening that was sufficiently small to interact with them.Its possible that some portion of the endoscope working channel was constricted and impinged on the stent as it passed through such as the elevator mechanism of the endoscope.The likely impingement of the stent then prevented the withdrawal of the guiding catheter resulting in the damage experienced.It was also noted that the endoscope model and working channel size could not be confirmed which could have contributed to the issues experienced.Summary: complaint of advancement issues is confirmed based on customer testimony, damage to device was confirmed in the laboratory which was most likely a result of the advancement issue.The hub separation is not confirmed as this was observed to be intact on return of the device.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: SOLUS BILIARY STENT AND INTRODUCER SET
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9932697
• Report Number: 3001845648-2020-00238
• Device Sequence Number: 19564275
• Product Code: FGE
• UDI-Device Identifier: 10827002256726
• UDI-Public: (01)10827002256726(17)230109(10)C1697352
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K851962
• 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): 08/06/2020

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: 01/09/2023
• Device Model Number: G25672
• Device Catalogue Number: ZSS-10-5-RB
• Device Lot Number: C1697352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/03/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/07/2020
• Supplement Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1