MAUDE Adverse Event Report: LAKE REGION MEDICAL PREFORM GUIDEWIRE - SAFARI; WIRE GUIDE

Model Number H74939272L1

Device Problems Entrapment of Device (1212); Flaked (1246); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not received for analysis; therefore no physical or visual analysis of the product can be performed.The manufacturing batch lot was not provided therefore we were unable to review the device history records to confirm that the device met all material, assembly and inspection specifications prior to shipment.The device is expected to be returned for analysis.If additional information is received or the product is returned for analysis a follow-up medwatch report will be submitted.No product returned.

Event Description

The initial complaint stated: problems with the performance of the safari.On 08/23/2016 additional information was received making this incident reportable.The information stated: "during withdrawal from the lotus valve the safari would not stay in place and became stuck to the lotus catheter.Both were removed together.".

Manufacturer Narrative

The manufacturing batch lot was not provided therefore we were unable to review the device history records.The device was returned for analysis.As received, the specimen consists of one each clinically used proximal 116.5cm of the unidentified safari device; returned coiled, loose and double bagged within "zip-lock" style poly biohazard pouches.The specimen presents fracture of the core wire and several fractures of the coil wire; the proximal aspect of the distal-most coil wire fracture has sustained too much damage to determine the nature of the fracture.All material distal of the core wire fracture and the distal-most coil wire fracture is missing.The core wire fracture and the coil wire fractures in the body of the device appear consistent with ductile, tensile overload.The specimen also presents numerous bends of varying severity and frequency scattered over the length of the device.The outer coil wraps present extensive stretch and offset coil damage in addition to ptfe coating damage including removal.The offset coil damage results in localized oversized diameter to.04435".The proximal joint appears to be correct and intact by visual examination and by non-destructive testing.The complaint narrative does not make mention of any fracture to the safari wire; however, supplemental communications indicate the safari wire and lotus catheter were removed as a unit and returned as a unit, it is likely that the fracture occurred during post-clinical attempts to separate the two devices.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the evidence presented by the sample and the information provided by the supporting documentation, procedural and/or clinical factors appear to have impacted on the event as reported.If additional information is received a follow-up medwatch report will be submitted.

• Brand Name: PREFORM GUIDEWIRE - SAFARI
• Type of Device: WIRE GUIDE
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: jackie ohnsorg ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418516
• MDR Report Key: 5934913
• MDR Text Key: 54143122
• Report Number: 2126666-2016-00079
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130798
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2016

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
• Device Operator: Health Professional
• Device Model Number: H74939272L1
• Device Catalogue Number: 39272L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2016
• Initial Date FDA Received: 09/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 85 YR