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

Model Number 0052-3021

Device Problems Kinked (1339); Split (2537)

Patient Problems Perforation (2001); Blood Loss (2597)

Event Date 12/08/2017

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 reported this introducer was being used for insertion of the impella rp at the femoral vein.The patient was presented to the cath lab for rp placement post coronary artery bypass graft (cabg).When attempting to place the 23fr introducer for rp implant, the introducer was seen to be compromised at insertion and kinked/split.There was an iliac vein perforation, which did require stenting and between 4-6 units of blood product replacement.The devices involved with this procedure were used in the following sequence: 23fr introducer, followed by impella rp and a stent of unknown manufacturer.The outcome of the patient is stable.

Manufacturer Narrative

There were no manufacturing rejects or anomalies of this event type recorded in the device history records.The introducer sheath passed all in-process and qa final inspection steps before shipping to the customer; including visual, dimensional and leak testing.A review of complaints against this lot number identified no additional reports.Per the abiomed introducer sheath in-process and final inspection procedure it is mentioned in the visual inspection section: 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.Per the instructions for use (ifu) it advises: 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 23f 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.Upon evaluation of the returned product, it was found that there was a 7cm split in the sheath tube, starting at approximately 9cm from the distal end.There was also a kink in the sheath tube approximately 15cm from the distal end.As mentioned in the complaint, the patient's iliac vein was "very tortuous." putting any excessive stress on the sheath may cause it to kink, deform or break.It is believed this sheath was subjected to stresses beyond its capabilities during use out in the field.Returned device analysis reveals one 23f abiomed introducer sheath that is within manufacturing specifications.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.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 was received indicating the following: an lmpella rp was prepared to support an 85 year old male patient in cgs post-cabg.The physician had difficulty manipulating the rp so that the outlet cage sat in the pa.During this manipulation, the 23 fr oscor introducer sheath split and the 11 fr rp catheter exited the introducer.An iliac vein perforation was discovered.The pump and introducer were removed and the perforation was repaired with covered stents.Damage was found at the outlet of the rp.Placement was aborted.The representative reported that physician said the patient's iliac vein was "very tortuous.".

• Brand Name: INTRODUCER KIT FOR IMPELLA
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 7213306
• MDR Text Key: 98046046
• Report Number: 1035166-2018-00007
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00813502010558
• UDI-Public: 00813502010558
• 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: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Model Number: 0052-3021
• Device Catalogue Number: 0052-3021
• Device Lot Number: C1-12952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR