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 Codes	Device Issue (2379); Positioning Problem (3009)
Health Effect - Clinical Codes	Atrial Perforation (2511); Blood Loss (2597)
Date of Event	03/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All disposables including the guide-wire and introducer were discarded following the event.As the product was not returned, no root cause can be determined.The console data logs are not relevant to this failure.Based on the clinical account, it is likely the proglide perclose used during the "preclose" technique originally perforated the artery, which the 0.035" then went through, and the 12fr dilator increased the size of the perforation when it followed the wire, but this cannot be verified.A review of the device history record revealed that there had been on other complaint associated with this failure mode.The root cause of the dilator perforating the patient's artery was unable to be definitively determined.(b)(4).
Event or Problem Description
The complainant reported that a (b)(6) year old female patient was transferred to this facility for an hrpci procedure.In preparation of providing impella cp support the physician dilated the left iliac, but encountered an issue when advancing the wire.The physician then placed a bentson wire through the 14fr dilator.Then imaging revealed that the dilator perforated the left iliac.The physician then crossed over from right iliac and inflated a peripheral balloon to help control bleeding.The vascular surgeon then performed a cut down and repaired the perforation.A 7fr sheath was placed above the perforation, and the doctor then successfully placed an impella cp inside the right iliac without issue.As a result of the perforation the patient received 6 units of packed red blood cells and plasma.Following the procedure the patient was reported to be stable and doing extremely well.Follow-up information was received from the physician, who stated that he feels the proglide perclose created a new pathway and the benson wire exited the artery and the dilator followed resulting in the event.

• 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: 7446542
• Report Number: 1220648-2018-00024
• Device Sequence Number: 1125197
• Product Code: DYB
• UDI-Device Identifier: 00813502010244
• UDI-Public: 00813502010244
• Combination Product (Y/N): N
• PMA/510(K) Number: P1400003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 01/31/2020
• Device Model Number: OSCOR INTRODUCER KIT, 14 FR X LONG
• Device Catalogue Number: 0052-3025
• Device Lot Number: 1327044
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARMADA PERIPHERAL BALLON; COOK BENTSON WIRE; PROGLIDE PERCLOSECOOK'S BENTON WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR