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

Model Number 0052-3025

Device Problem Difficult to Remove (1528)

Patient Problems Cardiomyopathy (1764); Mitral Regurgitation (1964); Blood Loss (2597)

Event Date 11/20/2017

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

The customer wanted to notify the manufacturer of a recent complaint that was relayed to them by a field representative on 11/20/2017: what is the outcome of the patient? stable.What procedure was the product used for? insertion/access for an impella cp at the left femoral artery.What was the condition of the patient when presented to the physician? the patient had known cardiomyopathy, severe takotsubo, cad, and mr was there an issue with the product unknown at this time, awaiting more details from field rep.When was the issue identified? during procedure.What was the user doing when the issue occurred? after insertion, the md was peeling away and lost 1 unit of blood, as there was an inability to remove peel away completely from femoral before cracking the sheath.Was there any additional devices used during the procedure? no.In which sequence the devices were used if multiple devices were involved? awaiting more details from rep in field regarding serial dilations and other case particulars.Are the devices available to return for evaluation? noted to be discarded.Additional information received on 11/27/2018: the updates i have for you are as follows: the patient is listed as "doing well" as of (b)(6) 2017.The impella has been explanted.Patient is a (b)(6) male.The patient had the impella cp placed for hemodynamic support of a cardiomyopathy patient.The bleeding did not extend the hospitalization, nor were blood products given.Regarding the inability to remove the peel away, the rep has yet to respond with much more details beyond what i initially had for you.The representative was not present at the insertion to witness the issue.The rep has been able to tell us that the patient was not obese and that the serial dilations were done.The blood loss is estimated at 1 unit.Yes, the introducer was discarded.

Manufacturer Narrative

A review of device history record (dhr) was conducted and there were no manufacturing rejects or anomalies of this type recorded in the dhr.The device passed all in-process and qa final inspection steps before shipping to the customer including visual, dimensional and leak testing.A complaint review of the reported lot identified one additional report for an unrelated event.The procedure, adelante s2s introducer sheath in-process and final inspections, ensures sheaths are inspected for visual, dimensional, and peel functional compliance.The destructive testing sampling plan instructs to: manually break the sheath and hub and verify that the seals split easily without extreme elongation.Also verify that the split cap and seals remain secure and do not break free or loosen from the sheath hub.It also instructs to "manually peel the sheath and verify the sheath peels easily along the sheath body and tip".Please note that this product is supplied bulk non-sterile without an ifu (instructions for use) to the customer for further processing.Since the device was discarded, it will not be returned for analysis and as a result, the allegations against this introducer cannot be confirmed.No subsequent device or clinical adverse events have been reported.Based on the investigation a capa is not required.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.

Event Description

Additional information received indicates that the blood lost was approximately 500 cc.Information received states the physician was forced to peel away the sheath, with part of the sheath still within the vasculature, due to the introducer being up against the impella pump plug.As per the reporter, the introducer used in this case was the 14f, 25 cm introducer (as opposed to the 14f 13 cm option).

• Brand Name: ABIOMED 14F INTRODUCER KIT FOR IMPELLA
• 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: 7105422
• MDR Text Key: 94480240
• Report Number: 1035166-2017-00110
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00813502010664
• UDI-Public: 00813502010664
• 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: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/01/2020
• Device Model Number: 0052-3025
• Device Catalogue Number: 0052-3025
• Device Lot Number: C1-13578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2017
• 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): Hospitalization
• Patient Age: 84 YR