MAUDE Adverse Event Report: LAKE REGION MEDICAL ZIPWIRE HYDROPHILIC GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	M00146154B1
Medical Device Problem Codes	Stretched (1601); Material Deformation (2976); Material Integrity Problem (2978); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided at the time of this report.Additionally, the lot number was not provided and therefore the actual place of manufacture could not be determined.The device was not received for evaluation at the time of this report; therefore, no physical analysis of the device can be performed.Additionally, lot traceability was not provided.The lack of lot traceability prevents performing a device history records review for any indication of manufacturing defect or anomaly that could have impacted on the event as reported.A review of the manufacturing processes indicates the production operators are instructed to 100% visually and tactilely inspect for any obvious defect, which includes a tactile examination of the entire length of each wire.In addition, during packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment.As indicated in the device instructions for use, warnings, "to prevent possible tissue damage, care should be taken when manipulating a device over a zipwire hydrophilic guide wire during the device's placement or withdrawal.If resistance is felt during device placement, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, remove the zipwire hydrophilic guide wire and device as a unit to prevent possible damage and/or complications." there is no indication of patient injury due to the zipwire in the event description.The reporting decision was based, in good faith, on the report that the zip wire "appeared to be frayed and stringed out/elongated".At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided, it appears that clinical and/or procedural factors impacted on the event as reported.If there is any further relevant information provided, a follow up medwatch report will be submitted.
Event or Problem Description
Event description: it was reported that: procedure type: abdominal angiogram.Description of the event: the rubicon catheter tip broke off into the patients aorta.The operator used a snare to retrieve the broken catheter tip.They were able to successfully retrieve the tip.The account would like to know why the rubicon catheter tip fell apart thank you the zip wire was pulled out of the catheter and it appeared to be frayed and stringed out/elongated.Devices are being returned as soon as rga is available.What troubleshooting steps took place? the operator used a snare to retrieve the broken catheter tip.Medical/surgical interventions: snared the device out product - g/wire 035/260 angled (bx5), model number: 46-154b, upn: m00146154b1, lot/serial number: unknown.Was the device implanted or did an attempt to implant occur?: no.Failure modes related to this device include: bent or kinked.Were the issues present upon opening the package?: no.Do you have a photo, video, or screenshot depicting the issue?: no.
Event or Problem Description
Event description: it was reported that: procedure type: abdominal angiogram.Description of the event: the rubicon catheter tip broke off into the patients aorta.The operator used a snare to retrieve the broken catheter tip.They were able to successfully retrieve the tip.The account would like to know why the rubicon catheter tip fell apart thank you the zip wire was pulled out of the catheter and it appeared to be frayed and stringed out/elongated.Devices are being returned as soon as rga is available.What troubleshooting steps took place? the operator used a snare to retrieve the broken catheter tip.Medical/surgical interventions: snared the device out.Product - g/wire 035/260 angled (bx5), model number: 46-154b, upn: m00146154b1, lot/serial number: unknown.Was the device implanted or did an attempt to implant occur?: no.Failure modes related to this device include: bent or kinked.Were the issues present upon opening the package?: no.Do you have a photo, video, or screenshot depicting the issue?: no.
Additional Manufacturer Narrative
Device evaluation: as received, the specimen consisted of one-1 each hydro gw std an 260-035; returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The specimen presented an overall length of 261.55cm and a finished diameter of.03325" to.03380".The specimen coating appeared visually and tactilely consistent when examined at 1x - 18 inches, unaided, wet.The specimen presented bend/kink damage over the distal 6.50cm with approximately 0.40cm of the metallic core wire protruding distally through the polymer jacket material.The damage presented by the specimen wire appeared consistent with manipulation of the wire against resistance.Our investigation was unable to confirm that the product did not meet specification prior to shipment.The investigation concluded that the product met specification at the time of shipment.As indicated in the device instructions for use, warnings, "to prevent possible tissue damage, care should be taken when manipulating a device over a zipwire hydrophilic guide wire during the device's placement or withdrawal.If resistance is felt during device placement, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, remove the zipwire hydrophilic guide wire and device as a unit to prevent possible damage and/or complications." the lack of lot traceability prevents performing a device history records review for any indication of manufacturing defect or anomaly that could have impacted on the event as reported.During manufacturing the production operators are instructed to 100% visually and tactilely inspect for any obvious defect, which includes a tactile examination of the entire length of each wire.In addition, during packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided and the evidence presented, it appeared that clinical and/or procedural factors have contributed to the event as reported.If there is any further relevant information provided, a follow up medwatch report will be submitted.

• Brand Name: ZIPWIRE HYDROPHILIC GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 12315996
• Report Number: 9680001-2021-00075
• Device Sequence Number: 19628369
• Product Code: DQX
• UDI-Device Identifier: 08714729754732
• UDI-Public: 08714729754732
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K000011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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 Model Number: M00146154B1
• Device Catalogue Number: 46-154B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1