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

Model Number UNKNOWN

Device Problems Entrapment of Device (1212); Kinked (1339)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

The manufacturing batch lot was not provided so a review the device history records for the guidewire involved in this incident could not be performed.The device was not received for analysis; therefore no physical analysis of the product could be performed.The product was reportedly disposed of by the user.Questions have been submitted to the distributor to try to obtain additional information for this incident including the event date and location.Based on the information received to date an exact cause for the incident could not definitely be determined.If additional information is received a follow-up medwatch report will be submitted.

Event Description

As reported; "guide wire was not adequately controlled.Forwarding the symetis tf delivery system made loops in descending aorta and finally kinks in the wire did not help delivery system could not be forwarded.Pulling back did not work upper crown opened and made dissection.Patient died.".

Manufacturer Narrative

The manufacturing batch lot was not provided so a review the device history records for the guidewire involved in this incident could not be performed.The device was not received for analysis; therefore no physical analysis of the product could be performed.The product was reportedly disposed of by the user.Questions were submitted to the distributor to try to obtain additional information for this incident including the event date and location.It was reported that the even date occurred at an unknown date in 2015.Photos taken after use were alo provided.The customer supplied images presented offset/overlapping coil damage in both the large and small radius curves in the distal region.A large overview image presented bend damage visible in the portions of the safari wire extending both distal and proximal of the symetis tf ds system.The damage presented to the distal region of the safaris wire appears consistent with withdrawing the wire against resistance.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, clinical and/or procedural factors appear to have impacted on the event as reported.No additional information has been provided.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: 6968783
• MDR Text Key: 89958968
• Report Number: 2126666-2017-00111
• 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: 11/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR