MAUDE Adverse Event Report: LAKE REGION MEDICAL PREFORM GUIDEWIRE - SAFARI2; WIRE GUIDE

Model Number H74939407S0

Device Problems Flaked (1246); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

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

Event Date 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

The manufacturing batch lot was provided.A review the device history records for the guidewire involved in this incident revealed the product met specification prior to shipment.The device was not received for analysis; therefore no physical analysis of the product can be performed.Based on the information provided to date an exact cause for the incident could not definitely be determined.The product is expected to be returned for analysis but had not been received by the time this report was submitted.If the product is returned or additional information is received a follow-up medwatch report will be submitted.Product is expected to be returned.

Event Description

During advancement of the lotus device through the aortic arch the safari2 wire was inadvertently pulled out of the left ventricle to the ascending aorta.The implanters in order to re-cross with the safari2 the annulus, decided to pull out the lotus valve first.In that point and after the delivery system was completely out of the patient, it was totally stuck over the wire.The wire could not be pushed or pulled at all.Safari2 and lotus valve decided to be replaced.The patient finally got successfully treated with new of the same products.

Manufacturer Narrative

This is a follow-up to the originally submitted medwatch report as the guidewire was returned for analysis.The manufacturing batch lot was provided.A review the device history records for the guidewire involved in this incident revealed the product met specification prior to shipment.The device was returned for analysis on february 28, 2017.As received, the specimen consisted of one each safari2 275cm sml crv; returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The lotus device was not returned with the safari2 specimen; therefore the complaint of the lotus valve being "totally stuck over the"safari2 could not be confirmed.The returned guidewire presented several bends of varying severity and frequency scattered over the length of the device and offset/overlapping coil wraps in the shaped distal region and scattered over the proximal 33.3cm.The ptfe coating was scraped and frayed in the vicinity of the offset/overlapping coil wraps and near the proximal end.Both proximal and distal joints were correct and intact by visual examination and by non-destructive testing.Except for the noted damage the guidewire was visually and dimensionally correct.It was 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.If additional information is received a follow-up medwatch report will be submitted.

• Brand Name: PREFORM GUIDEWIRE - SAFARI2
• 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: 6330430
• MDR Text Key: 67442870
• Report Number: 2126666-2017-00012
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: K151244
• 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: 03/13/2017

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: Physician
• Device Expiration Date: 09/30/2018
• Device Model Number: H74939407S0
• Device Catalogue Number: 39407S0
• Device Lot Number: 10610289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 02/14/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR