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

Model Number	G21396
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2019
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
Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent kinked/bent'.During the preparation for the procedure, the physician noticed there was a burr on the edge of the stent and decided it was dangerous.Therefore, the complaint device was exchanged with another manufacturer¿s stent to complete the procedure.The complaint device did not contact with the patient.Additional information on sep 10th by (b)(6): regarding what "burr" is, i received additional information from the rep.The physician¿s comment: the doctor indicates that ¿burr¿ is at the hole which seems to be created by perforating of a wire guide.(please see the photo of ¿pr275733 enlarged view of the complaint point indicated by the doctor¿) however, the doctor says that he did not insert a wire guide into the device.When he opened the package, the device already had the hole and burr.Sales rep¿s comment: i checked the photos of the returned device.As pointed out by cr team of (b)(6) it seemed that a wire guide was used and perforated the device though the physician says he did not use a wire guide.I accept any investigation results.You can write the results as they are in the customer report.
Event or Problem Description
Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent kinked/bent'.During the preparation for the procedure, the physician noticed there was a burr on the edge of the stent and decided it was dangerous.Therefore, the complaint device was exchanged with another manufacturer¿s stent to complete the procedure.The complaint device did not contact with the patient.Additional information on sep 10th by (b)(6): regarding what "burr" is, i received additional information from the rep.The physician¿s comment: the doctor indicates that ¿burr¿ is at the hole which seems to be created by perforating of a wire guide.However, the doctor says that he did not insert a wire guide into the device.When he opened the package, the device already had the hole and burr.Sales rep¿s comment: i checked the photos of the returned device.As pointed out by cr team of japan, it seemed that a wire guide was used and perforated the device though the physician says he did not use a wire guide.I accept any investigation results.You can write the results as they are in the customer report.
Additional Manufacturer Narrative
1 x zebd-7-7 of lot number c1594655 was returned to cirl open in its original packaging.A kink and perforation was observed on the 2nd porthole at the tapered end of the stent.A 0.035-inch wireguide would not pass the kink.A review of the manufacturing records for zebd-7-7 of lot number c1594655 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 c1594655.The instructions for use, which accompanies this device instructs the user to ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ also, the user is instructed by the instructions for use, : ¿care must be exercised when straightening the pigtail curls* in order to avoid kinking or breaking the stent.¿ there is no evidence to suggest that the user did not follow the instructions for use.A definitive root cause cannot be determined, as the circumstances of use cannot be replicated in the laboratory and due to limited information.A possible cause of this complaint may be that the kink occurred while being straightened as it was being loaded onto the wire guide.Complaint is confirmed as the failure was verified in the laboratory.According to the information reported, 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: ZIMMON BILIARY STENT SET
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9103370
• Report Number: 3001845648-2019-00484
• Device Sequence Number: 2430574
• Product Code: FGE
• UDI-Device Identifier: 00827002213968
• UDI-Public: (01)00827002213968(17)220312(10)C1594655
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019

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: No Information
• Device Expiration Date: 03/12/2022
• Device Model Number: G21396
• Device Catalogue Number: ZEBD-7-7
• Device Lot Number: C1594655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/26/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1