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

Model Number	0052-3014
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up will be submitted as soon as the investigation is complete.
Event or Problem Description
On july 5, 2018 the customer was notified that an incident occurred during a surgical procedure for placement of an impella cp on (b)(6) 2018.The patient was admitted for a high risk coronary angioplasty; turned down for bypass surgery.The field rep reports the hub cap separated during insertion, another oscor introducer was placed.It was reported that during the placement of the second introducer there was a minimal procedure delay.There was no medical intervention or adverse patient impact reported.

• Brand Name: ABIOMED 14F INTRODUCER KIT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• MDR Report Key: 8418566
• Report Number: 1035166-2019-00016
• Device Sequence Number: 1612466
• Product Code: DYB
• UDI-Device Identifier: 00813502011562
• UDI-Public: 00813502011562
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2021
• Device Model Number: 0052-3014
• Device Catalogue Number: 0052-3014
• Device Lot Number: C1-14098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR