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

Model Number M00146316B1

Device Problems Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not received for evaluation at the time of this report; therefore, no physical analysis of the device can be performed.It was reported that the device was used to facilitate stent implantation for intestinal stenosis.Please note that this model of zipwire hydrophilic guidewire is intended to facilitate placement of devices during diagnostic and interventional procedures and is labeled as such.A review of the device history records of the specimen device does not present 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.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.As indicated in the device instructions for use, warnings: do not manipulate or withdraw the zipwire hydrophilic guide wire through a metal entry needle or metal dilator.Manipulation and/or withdrawal through a metal entry needle or metal dilator may result in destruction and or separation of the outer polyurethane coating, requiring retrieval.A plastic entry needle is recommended when using this wire for initial placement.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.If any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the zipwire¿ hydrophilic guide wire and/or catheter and determine the cause under fluoroscopy.Failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter or damage to the vessel." , at this time, it is not possible to assign a definitive root cause for the event as reported.If there is any further relevant information provided, a follow up medwatch report will be submitted.

Event Description

Event description: it was reported that the guidewire entered the intestine, the tip fell off without crossing the lesion, and the coating remained in the patient's body, and then the tip was removed by snare.The device is expected to be returned before sep.13th.There were no patient complications reported.All additional information below was provided to the manufacturer 4 september 2023: 28-august-2023 1.Per event description, "the guidewire entered the intestine, the tip fell off without crossing the lesion, and the coating remained in the patient's body".Please verify the following questions.A.Was it a partial or a complete separation? complete separation b.Was it a wire separation or was it the black polymer sleeve section that peeled off the wire? the black polymer sleeve section c.What intervention was done by the physician when the guidewire entered the intestine? the physician operated the guidewire normally, and there was no problem with proficiency d.What was the physician's assessment to for the coating remained in the patient's body? colonoscope and endoscopic biopsy forceps were used to remove.2.If available, please provide lesion characteristics: a.% of stenosis: 30-40%.B.Tortuosity: (none, mild, moderate, severe) mild.C.Calcification: (none, mild, moderate, severe) none.4-september-2023: 1.Please provide a listing and model of other devices used during the procedure, include the model, brand name, sizes, etc.Intestinal obstruction stent implantation was performed.Implantation of intestinal stent after using bsc guide wire, and the stent size is 25 x 60, other devices are unknown.2.Was there any patient injury reported? no.3.Was there visible damage to the device and/or its packaging prior to use? no.4.Did this event occur during insertion, advancement or withdrawal? insertion.5.Any resistance felt during insertion? yes.6.Did the physician encounter any resistance while advancing the zipwire to its intended location? yes.7.Did the physician encounter any resistance while removing the zipwire? yes.8.Was the zipwire advanced through a metal cannula or needle? zipwire -no.9.The complaint narrative refers to the tip and to the coating.Please confirm if any part of the guidewire remained in the patient.No.

Event Description

Event description: it was reported that the guidewire entered the intestine, the tip fell off without crossing the lesion, and the coating remained in the patient's body, and then the tip was removed by snare.The device is expected to be returned before sep.13th.There were no patient complications reported.All additional information below was provided to the manufacturer 4 september 2023: 28-august-2023 1.Per event description, "the guidewire entered the intestine, the tip fell off without crossing the lesion, and the coating remained in the patient's body".Please verify the following questions.A.Was it a partial or a complete separation? complete separation b.Was it a wire separation or was it the black polymer sleeve section that peeled off the wire? the black polymer sleeve section c.What intervention was done by the physician when the guidewire entered the intestine? the physician operated the guidewire normally, and there was no problem with proficiency d.What was the physician's assessment to for the coating remained in the patient's body? colonoscope and endoscopic biopsy forceps were used to remove 2.If available, please provide lesion characteristics: a.% of stenosis: 30-40% b.Tortuosity: (none, mild, moderate, severe) mild c.Calcification: (none, mild, moderate, severe) none 4-september-2023: 1.Please provide a listing and model of other devices used during the procedure, include the model, brand name, sizes, etc.Intestinal obstruction stent implantation was performed.Implantation of intestinal stent after using bsc guide wire, and the stent size is 25 x 60, other devices are unknown 2.Was there any patient injury reported? no 3.Was there visible damage to the device and/or its packaging prior to use? no 4.Did this event occur during insertion, advancement or withdrawal? insertion 5.Any resistance felt during insertion? yes 6.Did the physician encounter any resistance while advancing the zipwire to its intended location? yes 7.Did the physician encounter any resistance while removing the zipwire? yes 8.Was the zipwire advanced through a metal cannula or needle? zipwire -no 9.The complaint narrative refers to the tip and to the coating.Please confirm if any part of the guidewire remained in the patient.No.

Manufacturer Narrative

Device evaluation: as received, the specimen consisted of one-1 each hydro gw std an 260-035; returned loaded within dispenser assembly without luer lock and double-bagged within large "zip-lock" style poly biohazard pouches.The specimen presented an overall length of approximately 275.5 cm and a finished diameter of.03320" to.03380".A gage bushing certified to be.0350" passed over the length of the specimen with no more effort than the mass of the bushing sliding down the wire shaft unaided, except by gravity till the proximal end of the polymer jacket material damage.Note all diameter measurements were acquired with a non-contact, toolmakers scope after allowing the specimen device to become dry after hydrating the specimen device with blood-bank saline.After flushing the specimen with blood-bank saline, the specimen was subjected to visual and tactile examination.The specimen coating appeared visually and tactilely consistent when examined at 1x - 18 inches, unaided, wet.The specimen presented damage to the polymer jacket material 0.1cm from the distal tip by exposing the underlying metallic core wire; the missing polymer jacket material was not returned with the specimen.Except where noted, the specimen device appeared visually and dimensionally correct.The nature and extent of the damage presented appears consistent with manipulation of the wire against resistance.As indicated in the device instructions for use, warnings: - do not manipulate or withdraw the zipwire hydrophilic guide wire through a metal entry needle or metal dilator.Manipulation and/or withdrawal through a metal entry needle or metal dilator may result in destruction and or separation of the outer polyurethane coating, requiring retrieval.A plastic entry needle is recommended when using this wire for initial placement.- 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.- if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the zipwire¿ hydrophilic guide wire and/or catheter and determine the cause under fluoroscopy.Failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter or damage to the vessel." a review of the device history records of the specimen device does not present 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.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.It was reported that the device was used to facilitate stent implantation for intestinal stenosis.Please note that this model of zipwire hydrophilic guidewire is intended to facilitate placement of devices during diagnostic and interventional procedures and is labeled as such.At this time, it is not possible to assign a definitive root cause for 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
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): VENUSA DE MEXICO S. DE R.L. DE C.V.; calle hertz 1525; parque industrial a j bermudez; ciudad juarez, chihuahua 32470 ; MX 32470
• Manufacturer Contact: victoria foss ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418506
• MDR Report Key: 17732258
• MDR Text Key: 323222260
• Report Number: 9680001-2023-00115
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729754862
• UDI-Public: 08714729754862
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K000011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00146316B1
• Device Catalogue Number: 41656
• Device Lot Number: JRZ7549363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 60 KG