MAUDE Adverse Event Report: OSCOR INC. SAFESEPT TRANSSEPTAL GUIDEWIRE SS-135; TROCAR

Model Number SS-135

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/29/2016

Event Type  malfunction  

Manufacturer Narrative

Conclusion not yet available, evaluation in process.

Event Description

The customer reported they received a phone call from the facility indicating a procedure was just completed using the safesept ss-135 and they believe the j tip broke off in the patient's body and is still believed to be in there.

Event Description

Additional information was received indicating the following: the distal portion that broke off has not been confirmed to be inside of the patient, but additional patient scans are going to be performed.The condition of the patient was reported to be fine and the patient was sent home.In an subsequent request for information the reporter replied that they " we were not able to receive any additional information from the center.".

Manufacturer Narrative

The following sections were updated in follow-up #1.Product problem: based upon review of complaint and additional information received, the complaint category is changed from serious injury to reportable malfunction.(b)(4).A review of device history record (dhr) was conducted and there were no manufacturing rejects or anomalies of this type recorded in the dhr.The device passed all in-process and qa final inspection steps before shipping to the customer.A complaint review of the reported lot found no additional reports involving this lot number.One guidewire was received coiled in a sealed pouch with no identification.The guidewire was free of kinks.Bending of the wire was observed at the j-tip end resulting in the inner wire being exposed and completely removed from outer coil j-tip end.Under 50x magnification using a keyence confocal laser microscope, more information relating to the nature of the failure was uncovered.Material is missing from the main body of the shaft.As the analysis indicates, this was most likely from the sharp point of the catheter applying force to that area and the material failing.Scarring along the top of the device are thought to come from scraping along the stainless steel catheter upon forceful removal or entry.Micro-fractures are present along the top portion of the sample.The presence of these micro-fractures indicated yielding that would not be caused from a normal manufacturing process.This was the result of extreme bending that exceeded the mechanical properties of the nitinol wire.The manufacturing and quality procedures were reviewed specifically for the handling and inspection of the j-tip area.Pull test data was collected from a different lot than the sample part.The data all exceeded the specification by 10 times on average.The test samples consistently broke at the location where the wire is flattened, not where the returned unit broke.After analysis it is clear that the fracture was generated from bending the wire sideways, most likely against the sharp point of the catheter.At this time no gaps could be found in the manufacturing and inspection processes for handling and inspection of the j-tip area.There is an overall inspection of the j-tip that says to check for bending and damage.Pull testing performed attempted to fatigue the wires by forming them once, twice, then 5 and 10 times.No correlation between forming (bending and heating) multiple times and lower pull tests could be established.It is indicated in the transseptal trocar final inspection procedure, physical inspection section, "using a magnification light, verify parts are free of any defects or damages (scratches, nicks, bumps, fm, etc.).Printed markers are to be free from visible gaps exceeding 0.5 mm2 (tappi std).Printed markers are to be white and fully printed around the wire.Per instructions for use (ifu) it states "at no time should the guide wire be advanced when resistance is met without first determining the cause by fluoroscopy and taking remedial action.Confirm proper location of the safesept¿ transseptal guidewire with fluoroscopy prior to proceeding." the process documentation was reviewed for a situation where undue stress was applied in the fashion noted on the returned samples.No such situation was found.Historical pull test data shows the facture location to be at the point where the wire is flattened, not at the taper from the main wire to smaller diameter near the distal end where fracture on the sample was.From the images collected and processes reviewed there cannot be a correlation established between a manufacturing process step and the failure mechanism found.The failure is most likely due to operator misuse of the device.At this time there has been no systemic problem found with the wire.Based on this information, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type.

• Brand Name: SAFESEPT TRANSSEPTAL GUIDEWIRE SS-135
• Type of Device: TROCAR
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 6197367
• MDR Text Key: 63064613
• Report Number: 1035166-2016-00193
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• PMA/PMN Number: K081986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/01/2019
• Device Model Number: SS-135
• Device Catalogue Number: SS-135
• Device Lot Number: DP04955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening