MAUDE Adverse Event Report: OSCOR INC ABIOMED 23F INTRODUCER KIT FOR IMPELLA; INTRODUCER, CATHETER

Model Number	0052-3021
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has been requested for retrieval but not yet received.A preliminary review showed there were no manufacturing rejects or anomalies of this event type recorded in the device history record.Conclusion is not yet available as the investigation is on-going.
Event or Problem Description
It was reported that on (b)(6) 2018, during an acute myocardial infarction/cardiogenic shock (ami/cgs) procedure, the 23fr introducer sheath fractured inside the vessel.It was during insertion of the impella rp pump that it was noted the 23f introducer sheath had fractured while inside the vessel.The fractured sheath was removed, a new 23f sheath was obtained and the procedure was completed, the impella rp was delivered.This (b)(6) male patient has history of runs of ventricular tachycardia and the pulmonary artery pulsatility index was trending down.It was reported that there was no injury to the patient nor any extended hospitalization.No further patient or incident information was provided.
Additional Manufacturer Narrative
The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.One 23 fr abiomed introducer sheath was received in a used condition with the dilator.No other accessories were received with this device.Blood was found on the exterior and interior of the sheath and side port tubing.Upon evaluation of the returned product, it was found that there were two splits in the sheath tube; 1.5cm and 3.5cm from the distal end.A kink was found in the sheath approximately 14cm from distal tip.There was also damage found around the circumference of the distal tip edge.The hemostasis valve was damaged/torn.The device did not fracture into separate pieces.The returned device had two splits and one kink in the sheath, a damaged/dented tip, and a torn/damaged hemostasis valve.Returned device analysis reveals one 23f abiomed introducer sheath that is within manufacturing specifications.No manufacturing defects were found.Potential contributing factors to the damages is if the device was advanced through an area of resistance (as stated in the precautions of the ifu), or if the device was subjected to unusual stresses (as stated in the handling and storage section of the ifu).As per procedure (abiomed introducer sheath in-process and final inspection), the devices in this lot were inspected as follows: 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.Per section 12.2, 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.Perform leak test as per procedure.Per ifu : 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.Avoid subjecting the device to unusual stresses.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.

• Brand Name: ABIOMED 23F 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: 7425373
• Report Number: 1035166-2018-00030
• Device Sequence Number: 1592361
• Product Code: DYB
• UDI-Device Identifier: 00813502010558
• UDI-Public: 00813502010558
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/01/2020
• Device Model Number: 0052-3021
• Device Catalogue Number: 0052-3021
• Device Lot Number: C1-13315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR