MAUDE Adverse Event Report: OSCOR INC. ABIOMED INTRODUCER 14F S13CM D21CM TKIT; INTRODUCER, CATHETER

Model Number 0052-3014

Device Problems Kinked (1339); Split (2537); Deformation Due to Compressive Stress (2889)

Patient Problem Death (1802)

Event Date 11/05/2017

Event Type  Death  

Manufacturer Narrative

Conclusion not yet available-evaluation in progress.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

What is the date of event? (b)(6) 2017.What is the name of the facility where event occurred? (b)(6).What is the outcome of the patient? (e.G.Patient stable, patient alive, no injury, serious injury, death) the patient expired.What procedure was the product used for? insertion of the impella cp.What was the condition of the patient when presented to the physician? the patient was admitted with cardiomyopathy.She had an aortic valve replacement and emergent 3 vessel cabg earlier in the week.Was there an issue with the product ? if yes , then provide details of the issue and answer the questions.Yes.When was the issue identified? (before , during or after the procedure) during removal of the 14fr introducer there was an observed kink and the peel away was cracked.What was the user (physician/ doctor/ nurse) doing when the issue occurred? removal of the introducer.Please provide the contact information of the physician who used the product to obtain additional clinical information of the event in question.N/a.What is the model number and lot no.Of the device used? 14fr x 13cm c1-13345.Was there any additional devices used during the procedure? no.What is the name, model no.And lot no.For any additional device used during the procedure? n/a.In which sequence the devices were used if multiple devices were involved? pending information from field rep regarding sequence of events.Are the devices available to return to oscor for evaluation? not yet returned to (b)(6).

Manufacturer Narrative

A review of device history record (dhr) was conducted and there were no manufacturing rejects or anomalies recorded in the dhr affecting released product.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 only 1 similar additional report involving this lot number.Per the adelante s2s introducer sheath in-process and final inspection procedure, it states the following regarding visual inspection: with naked eye at a distance of 12" to 18", verify the assembled sheath matches the drawing.Ensure parts are free of kinks, cracks, splits, sinks, excessive flash, loose/embedded fm, or any other damages.In the instructions for use (ifu) it indicates: never advance or withdraw guidewire or sheath when resistance is met.Determine cause by fluoroscopy and take remedial action.When injecting or aspirating through the sheath, use the sideport only.One 14f abiomed introducer sheath was returned from the customer.There were no other accessories.Blood was found on the exterior and interior of the sheath and side port.The sheath was kinked and the sheath tube was split.Upon evaluation of the returned product, it was found that there was a 7.6 cm split in the sheath tube starting at the distal tip.There was a kink in the sheath tube approximately 3.5 cm from the distal tip.There was also damage found around the circumference of the distal tip edge.Additional information received indicates that the patient's anatomy was a contributing factor to the failure mode observed.Putting any excessive stress on the sheath may cause it to kink, deform or break.Returned device analysis reveals one 14f abiomed introducer sheath that is within manufacturing specifications.No manufacturing defects were found and root cause of the failure 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.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.(b)(4).

Event Description

Additional information was received that indicated the following: the impella was attempted to be placed on (b)(6), at 10:15 am.The attempt was aborted, and patient expired on (b)(6) at 10:51 am.Salvage situation and access attempts were ceased.Physician's plan was to place impella cp for support.In the icu the patient coded during prep to ccl (cardiac care lab).Cpr started and continued thru out attempted impella insertion.In ccl sheath was being placed into right femoral.Impella was opened and prepped ready for implant.Visualization was poor during placement of pigtail and would not advance to the left ventricle.When fluoro visualization was made it showed the wire looped within artery.Decision was made to try the left femoral artery for access, but could not gain access to the artery.With no rosc (return of spontaneous circulation) procedure was aborted.The initial insertion was the same side as the a-line that was place post iabp.Physician said insertion was potentially lower than preferred.Angulation of stick is unknown.Patient was obese with large panis (an abnormal layer of fibrovascular tissue or granulation tissue).The lfa was not accessed due to active cpr low pulsatility.The venous was accessed only.Once right femoral sheath was removed it was notice that it was kinked and peel away was cracked.No issues were noted with the introducer device prior to the procedure.It was indicated that the physician did not attribute failure of impella as cause of death.

• Brand Name: ABIOMED INTRODUCER 14F S13CM D21CM TKIT
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer Contact: dorit segal ; 3816 desoto blvd; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 7022665
• MDR Text Key: 91747925
• Report Number: 1035166-2017-00097
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00813502010237
• UDI-Public: 00813502010237
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/01/2020
• Device Model Number: 0052-3014
• Device Catalogue Number: 0052-3014
• Device Lot Number: C1-13345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 03/29/2018
• Supplement Dates FDA Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2017
• 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 Outcome(s): Death