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

Model Number H74939271S

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2015

Event Type  malfunction  

Manufacturer Narrative

Reportable based on device analysis completed on 12/02/2015.It was reported that the device was not used in the patient - the issue was discovered outside the patient prior to use.The manufacturing batch record review confirmed that the device met all material, assembly and inspection specifications.As received, the specimen consists of one each clinically exposed, damaged safari wire 260cm sml crv device; returned coiled, loose, and single-bagged within a "zip-lock" style poly biohazard pouch.No other original packaging (casing) or other devices involved in the reported event is included.The specimen presents 7.25cm of the core wire exposed at the proximal end of the specimen terminated in a mechanical shear/cut, the proximal end of the 239.6cm long outer coil segment also presents a mechanical shear/cut in addition to torsional loading; the proximal coil to core weld and an indeterminate length of coil and core wire are missing and unaccounted for in the complaint documentation.The specimen also presents stretched coil wraps visible at 1x - 18" unaided at 207.5 to 218.0cm from the distal apex of the formed curve.No other damage or inconsistencies are noted to the specimen at this time.The distal joint appears to be correct and intact by visual examination and by non-destructive testing.It should be noted that this product undergoes a 100% non-destructive machine pull/proof test to verify weld integrity as part of the lot release inspection and testing.At this time it is not possible to determine an exact root cause for this event; however, 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.

Event Description

Safari wire opened from box, upon taking the safari small wire out of its casing it was noticed that the proximal end of the wire was disconnected and threaded.The wire was placed back in the casing and handed to the representative.

• 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: 5296054
• MDR Text Key: 33468653
• Report Number: 2126666-2015-00081
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K130798
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: H74939271S
• Device Catalogue Number: 39271S
• Device Lot Number: 10502902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR