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

Model Number M00146154B0

Device Problems Entrapment of Device (1212); Kinked (1339); Material Separation (1562); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not received for analysis; therefore, no physical or visual analysis of the device can be performed.The manufacturing batch record review confirmed the device met all material, assembly and inspection specifications.If any further relevant information is received, a follow-up medwatch report will be filed.

Event Description

Hydrophilic guide did not progress into catheter, becoming trapped.The use of force is necessary to remove the hydrophilic guide from inside the catheter and replacement by another.No patient complications and the patient condition is reported as stable.

Manufacturer Narrative

Device evaluation: as received, the specimen consists of one hydro gw std an 260-035; returned coiled, loose and double-bagged within large zip-lock style poly pouches.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.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The specimen presents a kink located 8.30cm from the distal tip and skive damage to the polymer jacket material 145.3 to 169.5cm from the distal tip and bunched polymer jacket material located 169.5 to 170.3cm from the distal tip.The specimen has sustained a fracture through the wire and polymer jacket material 193.2cm from the distal tip.The material proximal of the fracture is not included with the returned wire.The core wire fracture presents indications of a low cycle bending fatigue overload fracture; the polymer jacket presents indications of a ductile tensile overload fracture.At this time it is not possible to assign a definitive root cause for the event as reported.The damage presented by the specimen appears consistent with manipulating the wire against resistance.As noted in the warnings section of the device instructions for use (dfu), "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 the catheter and determine the cause by 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." based on the information provided, procedural and/or clinical factors appear to have impacted on 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
• MDR Report Key: 6965898
• MDR Text Key: 90747291
• Report Number: 2126666-2017-00104
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K000011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: M00146154B0
• Device Catalogue Number: 46-154B
• Device Lot Number: 10701877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 86