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

Model Number 0052-3025

Device Problem Break (1069)

Patient Problems Cardiomyopathy (1764); Death (1802); No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2018

Event Type  Death  

Manufacturer Narrative

Was intentionally left blank.Information is currently unknown.Conclusion not yet available, investigation on-going.

Event Description

The customer reported: what is the date of event? (b)(6) 2018.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) stable, on impella support at this time.What procedure was the product used for? insertion at the right femoral artery.What was the condition of the patient when presented to the physician? the patient has cardiomyopathy and "tortuous iliacs".Was there an issue with the product ? if yes , then provide details of the issue and answer the questions a) and b).Yes, the long 14fr x 25 cm oscor introducer had the orange portion of the hub come off.When was the issue identified? (before , during or after the procedure) in insertion there was profuse bleeding and the physician noticed the orange hub was off.What was the user (physician/ doctor/ nurse) doing when the issue occurred? inserting at rfa.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? unknown at this time.Was there any additional devices used during the procedure? 3 sheaths in total, all oscor.What is the name, model no.And lot no.For any additional device used during the procedure? unknown lot at this time.In which sequence the devices were used if multiple devices were involved? 14x25 cm oscor, bleed/remove, 14x13fr oscor for hemostasis, noted external iliac artery perforation, 10mm balloon, covered stent, new 14x25 cm oscor, impella 2.5.Are the devices available to return to oscor for evaluation? product hold at hospital at this time.

Manufacturer Narrative

As per additional information received march 2018 was reported date of death, actual day of death is unknown.Device evaluation anticipated, but not yet begun.Conclusion not yet available as the investigation is on-going.A follow-up will be submitted as soon as the investigation is complete.

Event Description

The customer provided the additional information: patient is a (b)(6) old male.Within representative notes on (b)(6) 2018 the patient expired but unsure what day, as it occurred over the weekend.There was no extended hospitalization.The patient had a previous catheterization and the team knew the vasculature was tortuous.Imaging was requested by the customer but none has been/or will be shared.It was reported there was profuse bleeding; the amount of blood loss is unknown however the patient received four (4) units.Upon insertion the bleeding was seen from the valve and immediately the introducer was replaced with the 14 x13 oscor.It was reported the orange portion of the hub came off.The product issue was resolved by using a second oscor introducer.The additional devices were used during the procedure a second introducer, a 10 mm balloon, and a covered stent.The customer was not given any details of the manufacturer, model or serial numbers, or lot numbers of the balloon or stent for the additional devices.The lot number of the introducer is unknown used in this procedure, however the customer was able to provide the model number 0052-3025.

Manufacturer Narrative

A review of device history record (dhr) could not be performed as the customer did not provide a lot number, however, inspection procedures require any oscor product to pass all in-process and qa final inspection before shipping to the customer.One 14f, 25cm long abiomed introducer sheath was returned from the customer with the dilator.There were two orange split caps returned, detached from the sheath's hub.There were no other accessories.Visible blood was found inside the sheath.The returned product was found to have adhesive on hub side a along with orange material from the split cap.Hub side b and both orange split caps showed no signs of visible adhesive residue.The returned device's orange split caps were separated from the device.The device had a small amount of glue on one side of the hub and no evidence on the other side of the hub or on either of the orange split caps.The lot number was not provided so we could not determine if the lot had any manufacturing rejects.All lots are visually inspected for properly placed and secure split caps and each lot performed destructive testing per a sampling plan to ensure the split cap remains fixed to the sheath.Based on the returned device analysis, it appears that the lack of glue on the hub/orange cap could have contributed to this failure.No manufacturing defects were found.Based upon the investigation, a corrective and preventive action has been initiated to address this issue.Oscor will continue to monitor this event type and risk.The event will be re-evaluated if additional information becomes available.Per qa adelante s2s introducer sheath in-process and final inspection procedure: "with naked eye at a distance of 12" to 18", verify the sheath hub and split caps are free of excess silicone oil applied between the seals during assembly.Verify split caps are properly placed and secured onto sheath hub and free of cracks/damages or excessive adhesive." additionally, destructive testing is performed per sampling plan.Inspector is to "insert dilator into sheath, lock dilator hub lock nut.Hold dilator hub with one hand and one of the sheath hub wing with the other hand.Bend the dilator hub to the side until dilator hub lock nut is disconnected from the sheath hub.Split caps should remain in place.There should be no damage and fracture to split cap and tabs." the instructions for use (ifu) informs the user: never advance or withdraw guidewire or sheath when resistance is met.Determine cause by fluoroscopy and take remedial action.

Manufacturer Narrative

Per instructions for use (ifu): once assembly is fully introduced into the vascular system, separate the dilator cap from the sheath valve housing by rotating the dilator cap off the hub.

• Brand Name: ABIOMED 14F INTRODUCER KIT FOR IMPELLA
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 de soto blvd.; palm harbor FL 34683
• Manufacturer (Section G): OSCOR INC.; 3816 de soto blvd.; palm harbor FL 34683
• Manufacturer Contact: dorit segal ; 3816 de soto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 7393771
• MDR Text Key: 104544875
• Report Number: 1035166-2018-00022
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 0052-3025
• Device Catalogue Number: 0052-3025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 64 YR