MAUDE Adverse Event Report: COOK IRELAND LTD PUSHING CATHETER; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G25092
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2018
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.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 "the pusher was introduced over a.018 wire (boston scientific nova gold) to push a stent.As they were pulling the pusher out it, was coiling on the wire.It was not coming out smoothly and the material was bunching up.They were able to eventually get the pusher pulled out along with the wire".
Event or Problem Description
As reported to customer relations "the pusher was introduced over a.018 wire (boston scientific (b)(4)) to push a stent.As they were pulling the pusher out it, was coiling on the wire.It was not coming out smoothly and the material was bunching up.They were able to eventually get the pusher pulled out along with the wire.".
Additional Manufacturer Narrative
(b)(4).Exemption number: e2016031.Information pertaining to manufacturer as follows: importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).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 "the pusher was introduced over a.018 wire (boston scientific nova gold) to push a stent.As they were pulling the pusher out it, was coiling on the wire.It was not coming out smoothly and the material was bunching up.They were able to eventually get the pusher pulled out along with the wire.".
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)(6) cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington, indiana 47402-4195.Importer site establishment registration number: (b)(6).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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.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 "the pusher was introduced over a.018 wire (boston scientific nova gold) to push a stent.As they were pulling the pusher out it, was coiling on the wire.It was not coming out smoothly and the material was bunching up.They were able to eventually get the pusher pulled out along with the wire.".
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).Device evaluation: 1 x pc-3 of lot # c1302069 was returned to cirl for evaluation in its original package opened.Lab evaluation: the device involved in the complaint was returned and evaluated in the laboratory on 03 dec 2018.On evaluation of the device it was found that the device was crumpled on several locations along first 80cm of one tube.Image review: n/a documentation and ifu review: a review of the manufacturing records for the device of lot # c1302069 did not reveal any discrepancy that would have contributed to the complaint issue, there is no evidence to suggest that this issue effects the entire lot # c1302069 ; upon review of complaints this failure mode has not occurred previously with this lot # c1302069.Prior to distribution pc-3 devices are subject to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It may be noted that the ifu is n/a for pushing catheter devices root cause: a definitive root cause could not be determined as the clinical conditions of use cannot be replicated in the laboratory.A possible root cause may be attributed to resistance encountered during placement of the stent, while it was reported that no resistance was encountered by the reporter, as per cirl engineering feedback under normal use conditions it may be difficult for the user to determine if resistance is being felt when using a pc-3 as the catheter is so small in diameter that it can compress more easily than the bigger pushing catheters at forces where the larger catheters would be unaffected.Summary: complaint is confirmed as the failure was identified and verified in the laboratory.As per provided info there was no harm caused to the patient complaints of this nature will continue to be monitored for emerging trends.
Event or Problem Description
As reported to customer relations "the pusher was introduced over a.018 wire (boston scientific nova gold) to push a stent.As they were pulling the pusher out it, was coiling on the wire.It was not coming out smoothly and the material was bunching up.They were able to eventually get the pusher pulled out along with the wire.".

• Brand Name: PUSHING CATHETER
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8119026
• Report Number: 3001845648-2018-00556
• Device Sequence Number: 1630944
• Product Code: FGE
• UDI-Device Identifier: 00827002250925
• UDI-Public: (01)00827002250925(17)191201(10)C1302069
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup,Followup,Followup
• Report Date (Section B): 02/14/2019

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: 12/01/2019
• Device Model Number: G25092
• Device Catalogue Number: PC-3
• Device Lot Number: C1302069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/08/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 11/08/2018; 11/08/2018; 11/08/2018; 11/08/2018
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 12/20/2018; 01/17/2019; 02/14/2019; 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1