MAUDE Adverse Event Report: OSCOR INC ABIOMED INTRODUCER 14F S13CM D18CM TKIT; INTRODUCER, CATHETER

Lot Number OR-04735

Device Problem Device Damaged Prior to Use (2284)

Patient Problem Hemostasis (1895)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

Conclusion not yet available, evaluation in process.This initial mdr is being submitted to meet our requirements of reporting.A follow-up will be submitted as soon as the investigation is complete.

Event Description

I would like to inform you of a complaint on the 14fr sheath that has been determined to be reportable due to the patient having significant groin bleeding that required vasculature to be repaired surgically.They physician was concerned that the damage to the sheath may have caused the damage to the artery.Abiomed does not have this product returned from the field at this time.I have listed the full salesforce narrative below.Please let me know if you have any questions.I believe there will be more information when the part returns from the field.Pt presented to ed nstemi early morning.Taken into cv lab to assess.Pt de-compensated and impella was placed per protocol.The 14fr sheath had some damage before use but was used due to no back up sheath and placed before i arrived.Coronaries were found to have severe disease in lad and rca, disease in circ balloon and des x3 to lad.Balloon and des to rca.At the end of the successful revasc peel away sheath was removed and repo sheath was placed.Pt's groin continued to bleed.Manual compression was held for over an hour but it would not stop.Phys was concerned that there may be damage to the artery from the 14fr sheath.Because the pt was doing well it was decided that impella would be removed in operating room (or) and artery surgically repaired.Impella was successfully weaned and removed in operating room (or).Sheath to be sent back to be examined.(b)(6) on site.What is the lot number of the device used? introducer kit, 14 fr, sterile (batch: or-04735) what is the name, model no.And lot no.For any additional device used during the procedure? only the impella cp and 14fr oscor sheaths were used.Are the devices available to return to oscor for evaluation? the 14fr sheath was returned for investigation to abiomed but will not be returned to oscor as it is a gen 1 sheath.Only gen 2 sheaths will be returned to oscor as those are our currently used sheaths.

Manufacturer Narrative

The device was not returned for analysis therefore the allegations against this device cannot be confirmed.There were no manufacturing rejects or anomalies of this event type recorded in the device history records.The introducer passed all in-process and qa final inspections before shipping to the customer, including visual, mechanical and dimensional tests.A review of complaints against this lot number identified no additional similar events.Per the quality assurance abiomed introducer sheath in-process and final inspection procedure it instructs the operators to use 10x magnification for visual inspection unless specified otherwise.Visual inspection includes verify the hub is smooth, has no cracks, no short shots, sinking or unfilled areas, check for foreign material, check hub shape, french size embossed on hub, and for excessive flash.Using 10x magnification look down into hub for irregularities; verify no splitting at break lines and a smooth transition between sheath and hub on inside of hub.Verify score lines are spaced evenly around the circumference of sheath tube; look down into the hub and verify score lines on sheath align with break line of the hub.Measure dimensions; verify sideport opening diameter using pin gauges; visually inspect the sideport hole is without any flash or blockage.Measure usable sheath length after over molding from end of hub to end of tube, using metric ruler.Verify i.D.And inner clearance of sheath by inserting a calibrated pin gauge into hub end, all the way through to the tip.Use go-no-go gauge for o.D.Verification; verify the full length passes through the gauge.Using 10x magnification, verify the tip is round, no flash, no splitting, cracks or other damages.Insert a tipped dilator through the tipped sheath and check if dilator inserts without excessive force or obstruction.With the naked eye, inspect where the sheath and dilator meet and check gap and that a smooth transition is present.Measure usable sheath length after tipping; from end of hub to tip of tube, using metric ruler.Measure tip i.D.Of sheath using pin gauge.Visual inspection with naked eye, ensure parts are free of kinks, cracks, splits, sinks, excessive flash, loose/embedded foreign material or any other damages.Verify split caps are properly placed and secured onto sheath hub and free of cracks/damages or excessive adhesive.Perform pressure and vacuum leak test and perform occlusion test.Assembly fit check, insert dilator into sheath, lock and unlock dilator hub lock nut for verification of proper fit; verify no gaps between sheath tip and dilator.The abiomed adelante s2 hemostatic peel-away introducer system with infusion sideport instructions for use (ifu) lists the following adverse effects and possible complications: air embolism, bleeding, hematoma formation and vessel damage.Precaution - aspiration and saline flushing of the sheath, dilator, and valve should be performed to help minimize the potential for air embolism and clot formation.Also, the ifu instructs the user to aspirate all air from the sheath valve assembly by using a syringe connected to the sideport.Flush the sheath with 5 cc of saline immediately before peeling the sheath away in order to minimize back bleeding since the device was not returned, a root cause could not be determined.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.In addition, there was no new failure mode identified and the risk remains acceptable.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.Oscor inc., is submitting the above report to comply with 21 cfr part 803, the medical device reporting regulation.The report is based upon information obtained by oscor inc., which the company may not have been able to investigate or verify prior to the date the report was required by fda.This report does not constitute an admission that the device, oscor, inc., or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, oscor, inc., or its employees, that the report constitutes an admission that the device, oscor, inc., or its employees caused or contributed to the event described in this report.

Event Description

Additional information regarding the reported incident was obtained and included the date of event being corrected.New information reflected date of event of 28 september 2017.The representative from reporting company was told that it was observed that there was "fraying" at the tip prior to insertion.Regardless of this noted damage the damaged sheath was used anyway as the facility did not have an extra introducer to replace it with.While having his cardiac catheterization, the patient was found to have multivessel coronary artery disease, which was intervened upon and stents were placed.During the revascularization, the impella cp was successfully supporting the patient.At the end of the intervention, the 14fr introducer was peeled away and the repositioning sheath placed.When this was done, there was noted bleeding at the groin access site.The team held pressure for one hour to achieve hemostasis but this was not effective.The physician chose to explant the impella cp and perform a surgical closure of the site.The impella cp was weaned and explanted.Post vascular repair and after closure the team had achieved hemostasis and the patient was no longer bleeding at the access site.

• Brand Name: ABIOMED INTRODUCER 14F S13CM D18CM TKIT
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd; palm harbor FL 34683 1816
• MDR Report Key: 7000647
• MDR Text Key: 91011666
• Report Number: 1035166-2017-00093
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K122084
• 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: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Lot Number: OR-04735
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention