MAUDE Adverse Event Report: OSCOR INC SAFESEPT TRANSSEPTAL GUIDEWIRE; TROCAR

Model Number SSNF

Device Problems Break (1069); Material Separation (1562)

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

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

A preliminary review showed there were no manufacturing rejects or anomalies of this event type recorded in the device history record.The product in question has been received and has entered the investigation process.Conclusion not yet available as the investigation is on-going.

Event Description

The physician was attempting to cross the septum and the safesept needle free transseptal guidewire (ssnf) would not cross, so he tried to cross two more times unsuccessfully and then removed the ssnf from the dilator only to find that the j tip had broken off.They removed the introducer and found the broken j lodged in the dilator.It was reported that there was no injury to the patient.

Manufacturer Narrative

A review of device history record (dhr) was conducted and determined the device was processed on a customer rework order.Per the special rework procedures, the inspector removes the product from packaging, advances the tip and checks for proper positioning, further advances the wire and checks for bends, kinks, or other damage on the guide wire for approximately the first 10 cm.The released 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.The transseptal guidewire is also inspected per established final inspection procedure.At an aql 1.0 inspection level, inspectors "using a magnification light (2.25x magnification), verify parts are free of any defects or damages (scratches, nicks, bumps, fm, etc.), using calipers or micrometers measure the flat thickness of the curved area to be 0.0040" +/- 0.0005", and run gloved hand/finger across the tip and coil.Radiopaque coil must not be damaged, move or dislodge.Using a 10x microscope, check the coil to make sure there is no damage on it.Ensure the coil is placed distally against the edge where the guidewire increases in diameter." instructions for use (ifu) is supplied with this product.Per the ifu, the user is to "advance the safesept transseptal guidewire until the tip enters the curved portion of the transseptal dilator (visible markers are provided as a guide for common commercially available transseptal introducer systems.Do not advance the guidewire beyond the tip of the dilator)." additionally, the ifu states, "under fluoroscopic guidance, while tenting and maintaining constant force on the septum with the dilator, slowly advance the safesept transseptal guidewire through the dilator, and across the interatrial septum, into the left atrium.Continue to advance into one of the pulmonary veins (the radiopaque coil on the guidewire should be seen to be within the left atrium and subsequently the pulmonary vein).At no time should the guidewire 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." one safesept needle free transseptal guidewire was received in two pieces.The j tip was received separated from the main wire.The nitinol portion of the guidewire with the coil (approximately 2 cm in length) that belongs in-between the two returned pieces was not returned.The guidewire was free of kinks.No other accessories were returned.Both pieces of the returned wire were visually examined and appeared to be curved slightly near the break point, meaning it exceeded the yield stress of the material before finally fracturing.Permanent deformation of the wire can be observed on both the j-tip portion and guidewire portion.In-between the returned j-tip and guidewire portion is where the nitinol portion with coil (not returned) would attach.The cross-section of both pieces show the granular structure of the material.The cross-section of the guidewire side and of the j-tip both displayed a portion of material coming off of the edge of the area.Scraping, divots and micro-fractures were observed along the j-tip and guidewire section due to excessive force.Micro-fractures would not be observed during the normal manufacturing process and would have occurred due to exceeding the yield stress on the nitinol wire.An indentation/pinch-point was observed on the guidewire section next to the location of the break where the wire was permanently deformed and curved.Returned device analysis reveals one safesept needle free transseptal guidewire within manufacturing specifications.The customer stated that they attempted to cross the septum a total of three times with the product.It is likely that these unsuccessful attempts resulted in abnormal forces at the point of fracture resulting in the max yield stress limit being reached and ultimately leading to fracture.The reason for return cannot be confirmed.No manufacturing defects were found.Based on the investigation, 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 and risk.

• Brand Name: SAFESEPT TRANSSEPTAL GUIDEWIRE
• Type of Device: TROCAR
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd; palm harbor FL 34683 1816
• MDR Report Key: 7484276
• MDR Text Key: 107987274
• Report Number: 1035166-2018-00040
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00891492002401
• UDI-Public: 00891492002401
• Combination Product (y/n): N
• PMA/PMN Number: K130843
• 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: 07/03/2018

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: 08/01/2018
• Device Model Number: SSNF
• Device Catalogue Number: SSNF
• Device Lot Number: CR01916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2018
• Initial Date FDA Received: 05/03/2018
• Supplement Dates Manufacturer Received: 06/27/2018
• Supplement Dates FDA Received: 07/03/2018
• Patient Sequence Number: 1