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

Model Number	M00146319B1
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No physical analysis of the device can be performed as the complaint information indicated the device was discarded.Additionally, the lot number was not provided; therefore, the actual place of manufacture could not be determined.Furthermore,without the lot number, manufacturing batch records for the complaint device cannot be reviewed.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.The complaint is non-verifiable as the product was not returned for evaluation.As indicated in the supplementary complaint information received 18 november 2021, "the dr.Believes it was an operator error and complexity of the disease.The wire was moved on accident by the scrub and or himself." at this time, it is not possible to assign a definitive root cause for the event as reported.Note that the recorded age is approximate and based on the supplementary complaint information.If there is any further relevant information provided, a follow up report will be submitted.
Event or Problem Description
It was reported that: time of the event: during the procedure.Procedure information procedure type: right sfa intervention what condition was the patient being treated for?: pvd.Description of the event: patient complications: dissection.Medical/surgical interventions: prolonged balloon inflation.Patient admitted to hospital beyond standard of care?: yes.Did device issues cause or contribute to the patient complications? no.Failure modes related to this device include: no device issues.Describe any patient symptoms that occurred related to the dissection: weight bearing pain.Was the dissection flow limiting? yes.What actions were taken as a result of the issue? prolonged pta.What bsc devices were used prior to dissection? zip wire.What is the anatomical location of the lesion being treated? tibial trunk.What was the type of dissection (a-f)? na.What was the vessel location of dissection? peroneal.What was the patient's status post-procedure? unknown.Additional information received 18 november 2021: 1.Clarification needed: did the zipwire have a role in the patient complications? ans: the dr.Believes it was an operator error and complexity of the disease.The wire was moved on accident by the scrub and or himself.2.Can the lot number be obtained? ans: discarded.

• Brand Name: ZIPWIRE HYDROPHILIC GUIDEWIRE
• Common Device Name: 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: 12870987
• Report Number: 9680001-2021-00200
• Device Sequence Number: 5748723
• Product Code: DQX
• UDI-Device Identifier: 08714729754961
• UDI-Public: 08714729754961
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Type of Report: Initial
• Report Date (Section B): 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M00146319B1
• Device Catalogue Number: 41616
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Race: White