MAUDE Adverse Event Report: ABIOMED, INC. OSCOR INTRODUCER KIT, 14 FR X LONG

Model Number	OSCOR INTRODUCER KIT, 14 FR X LONG
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	10/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The oscor 14 fr and abiomed 13 fr introducers were returned for evaluation.A review of the clinical case revealed the patient had multivessel disease which results in abnormal structure or tightening of the blood vessels.Both introducers were returned with kinking and deformation, which is indicative of the introducers meeting resistance during insertion.Without any visual evidence or imaging showing what the patient's vasculature looked like, it cannot be definitively determined what caused the resistance against the sheath.The sheath kinking, however, was the result of column buckling due to applied force that occurred while advancing the introducer during the case.A review of the device history did not reveal any nonconformities.(b)(4).
Event or Problem Description
An (b)(6) female patient with multivessel disease had an impella 2.5 placed for support for hrpci on (b)(6) 2017.This patient has a history of having a prior coronary artery bypass graft procedure.The left femoral artery was assessed prior to insertion of the impella.The 13 fr abiomed introducer was unable to be inserted and was found to be kinked.A 14 fr oscor introducer was attempted to be inserted, however the introducer was unable to be advanced.A second 13 fr abiomed introducer was able to be inserted and the impella 2.5 was advanced and support was initiated.The patient underwent a primary protected coronary intervention while on impella support.After the procedure the patient was weaned from the impella 2.5 and the pump was explanted.Two perclose sutures were used for closing the insertion site.At the end of the case a femoral runoff angiogram revealed vasculature tightness and poor flow to the left femoral artery.The clinical team decided to balloon and place a medtronic everflex stent; and flow was restored.There was no further adverse event to the patient following the stent placement.

• Brand Name: OSCOR INTRODUCER KIT, 14 FR X LONG
• Common Device Name: OSCOR INTRODUCER KIT, 14 FR X LONG
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• MDR Report Key: 7011149
• Report Number: 1220648-2017-00073
• Device Sequence Number: 800016
• Product Code: DYB
• UDI-Device Identifier: 00813502010244
• UDI-Public: 00813502010244
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P1400003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2017

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: 04/30/2019
• Device Model Number: OSCOR INTRODUCER KIT, 14 FR X LONG
• Device Catalogue Number: 0052-3015
• Device Lot Number: 1289197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/08/2017
• 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: Required Intervention
• Patient Age: 84 YR