MAUDE Adverse Event Report: OSCOR INC ABIOMED 14F INTRODUCER KIT FOR IMPELLA; INTRODUCER, CATHETER

Model Number	0052-3000
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Health Effect - Clinical Codes	Angina (1710); Calcium Deposits/Calcification (1758); Blood Loss (2597)
Date of Event	01/06/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The complainant reported that an (b)(6) female patient with 3-vessel disease was scheduled to have a subacute pci to be performed on (b)(6) 2017 with the aid of an impella cp.Good local arterial pulsation was found in both groins.A standard 6f femoral sheath was inserted into the right femoral artery and iliacography showed both iliac arteries as good caliber.A standard 6fr femoral sheath was inserted into the left femoral artery.5000 iu of heparin was administered intra-arterially.A long standard j-wire was advanced to the aortic arch.The sheath was then removed from the left groin and the impella cp arterial dilators were used with no resistance.The impella peel-away introducer was inserted into the artery.The wire moved freely, but following the removal of the introducer dilator there was no arterial flow in the sheath.The patient immediately deteriorated into shock due to severe bleeding from the left femoral artery, and was quickly intubated and ventilated.The complainant reported that during the insertion of the introducer it accidently peeled and damaged the vessel wall, requiring surgical repair.During the surgical procedure the patient was administered 6 units of blood.It was estimated that the patient lost a total of 2000 ml of blood.The punctured profunda artery and a traumatic lesion in the superficial femoral artery required repair.Both lesions successfully surgically repaired.Additional information was obtained from the complainant, which reported that the patient had very heavily calcified and tortuous vessels and the profunda artery was situated very deep and to the lateral.Due to this some degree of angulation of the sheath occurred during entry into the artery.Thus, the introducer dilator followed the bending and entered the artery, while the peel-away portion of the sheath was peeled off on the edge of the heavily calcified artery; consequently, the peel-away sheath ended up on the outside of the artery.This finding was confirmed visually during the surgical repair.The pci was aborted, and was scheduled for the following week.The impella cp supported the patient without issue, and the patient was hemodynamically doing fine.The device successfully supported the patient for approximately 25 days.
Additional Manufacturer Narrative
One 14f abiomed introducer sheath with dilator was returned from the customer.There were no other accessories.Blood was found on and inside the sheath and dilator.The introducer and dilator were both returned assembled together.The dilator provided has a bend of approximately 13 degrees.The bent section starts at approximately 45mm from the distal tip.Additionally, the o.D.And the i.D at the distal tip is distorted from the typical round dimension.Other than aforementioned issues the dilator passes visual inspection.The introducer provided passes visual inspection except for split at the tip that extents 9.8cm down the sheath.Additionally there is an indentation 2cm from distal tip 1cm wide.This area most likely buckled from the angulation force of the dilator.Dilator dimensions were measured all within spec.Sheath dimensions were measured all within spec.Upon evaluation of the returned product, it was found that the dilator most probably exerted extreme diagonal force, (determined by the bent tip on dilator) to the introducer and the indentation of the sheath.The diagonal force translated stresses to the tip of the introducer which caused it to split along one of the score lines.In addition the notation from the (senior interventional cardiologist) states that "artery was heavily calcified".The calcified artery may have helped cause the tip of the introducer to tear because the abrasive surface, further illustrated by the distorted dilator tip.The angular force applied during the procedure likely exceeded the design of the introducer.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.In addition, no new failure mode was 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.Per procedure (abiomed introducer sheath in-process and final inspection) 9.2.2 visual inspection: using 10x magnification, verify the tip is round, no flash protruding greater than 0.4 mm (0.016") and no flash with width (around circumference) greater than 0.7 mm (0.028"), no splitting, cracks or other damages.Slight discoloration from tipping process is acceptable.Verify proper tip shape according to drawing.Insert a tipped dilator of appropriate size through the tipped sheath and check if dilator inserts without excessive force or obstruction.With the naked eye at a distance of 12" to 18", inspect where the sheath and dilator meet and check the gap is minimal and a smooth transition is present.Per instructions for use (ifu): no representation or warranty is made that an oscor inc.Product will not fail.Oscor inc.Disclaims responsibility for any medical complications, including death, resulting from the use of its products.Except as expressly provided by this limited warranty, oscor inc.Is not responsible for any direct, incidental, or consequential damages based on any defect, failure, or malfunction of its products whether the claim is based on warranty, contract, tort, or otherwise.Some states do not allow the exclusion or limitation of consequential damages and so the above limitation or exclusion may not apply to you.

• Brand Name: ABIOMED 14F INTRODUCER KIT FOR IMPELLA
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd; palm harbor FL 34683 1816
• MDR Report Key: 6761331
• Report Number: 1035166-2017-00067
• Device Sequence Number: 13694284
• Product Code: DYB
• UDI-Device Identifier: 00813502011562
• UDI-Public: 00813502011562
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2018

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
• Operator of Device: Physician
• Device Expiration Date: 11/01/2019
• Device Model Number: 0052-3000
• Device Catalogue Number: 0052-3000
• Device Lot Number: C1-12829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/03/2017
• Supplement Date Received by Manufacturer: 07/03/2017
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR