MAUDE Adverse Event Report: OSCOR INC DIREX 12F 67CM LRGCRV CURVE DILATOR; INTRODUCER, CATHETER

Model Number	M004DS500
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	10/03/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
They thought that the dilator was way too tight and they didn't use at all but they opened it.The event happened during the procedure outside the patient's body.Unfortunately, they abandoned the case and they had to do cardiac tamponade to make sure to get the fluid or the blood outside the pericardium.No complications.Patient is stable and fine.
Additional Manufacturer Narrative
The following sections were updated in follow-up # 1.One direx 12f introducer sheath from lot# c8-09861 was received back from the customer with the dilator.There were no other accessories.No visible blood was found on the sheath or dilator.After review of the returned sheath it was found that the dilator would not pass through the id of the sheath, so the reason for return was confirmed.The dilator was inserted through the hemostasis valve of the sheath and there was resistance felt which didn't allow the dilator to pass fully through.The dilator was removed and the id of the sheath was inspected by inserting a pin gauge through the sheath.The pin gauge passed though the sheath with limited resistance.The id of the sheath is within the specification.The dilator od was inspected and it was found that the od of the dilator was out of specification per drawing.The max od of the dilator measured is above the max od of the spec.Returned device analysis reveals one direx 12f dilator where the od is out of spec.A corrective and preventive action was initiated to investigate the root cause and implement corrective action for this failure.

• Brand Name: DIREX 12F 67CM LRGCRV CURVE DILATOR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd; palm harbor FL 34683 1816
• MDR Report Key: 7004698
• Report Number: 1035166-2017-00095
• Device Sequence Number: 13582804
• Product Code: DYB
• UDI-Device Identifier: 08714729858980
• UDI-Public: 08714729858980
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K122960
• 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): 02/07/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 07/01/2020
• Device Model Number: M004DS500
• Device Catalogue Number: M004DS500
• Device Lot Number: C8-09861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 02/07/2018
• 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: Hospitalization
• Patient Age: 63 YR