MAUDE Adverse Event Report: OSCOR INC. 12F DIREX STEERABLE SHEATH; INTRODUCER, CATHETER

Model Number	M004DS500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation is still in progress ,follow up report will be submitted if we found any further additional information.
Event or Problem Description
It was reported that proximal end of dilator broke off during transseptal inside the patient body.The hub broke off after transseptal crossing when attempting to remove the dilator and wire from the sheath.Dilator was removed when the physician placed a clamp on it.There was no medical intervention required and no surgical delay reported.There was no adverse effects to the patient.No additional information is available.
Additional Manufacturer Narrative
Device used in treatment.One dilator from a 12f bsc direx introducer sheath kit was returned from the customer.The sheath was not returned and there were no other accessories.Blood was found on and inside the dilator.Upon evaluation of the returned product, it was found that the hub was detached from the proximal end of the dilator and not returned.There were crimp marks found on the proximal end of the dilator.This was likely caused from the physician removing the dilator with a clamp as stated in the event description.The rest of the dilator (including the distal tip) looked normal.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections the hub became detached from the dilator.Since the manufacture of the device, dilator was revalidated which narrowed down the correct bonding parameters.The hub of the dilator was not properly bonded during the molding process.The cause of the failure is improper dilator extrusion manufacturing and improper dilator hub manufacturing.This has been revalidated under a validation protocol and has been corrected since the date of manufacture of this specific dilator.The event will be re-evaluated if additional information becomes available.Per destino dilator in-process and final inspection: 8.1 visual inspection: hub to be round and smooth, no irregularities inside, fm as per section 7.At 12-18" distance, hub shape should be as per drawing, flash <0.75 mm or pinch should not exceed 0.2 mm (use profile projector if needed).8.2 measure id of dilator hub by inserting appropriate pin gauge through hub.Per ifu: never advance, torque, or withdraw sheath when resistance is met.Determine cause by fluoroscopy and then take remedial action.Capa is not required oscor will continue to monitor this event type and risk.The event will be re-evaluated if additional information becomes available.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: 12F DIREX STEERABLE SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• MDR Report Key: 8089927
• Report Number: 1035166-2018-00101
• Device Sequence Number: 16483533
• 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: K120459
• 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): 12/19/2018

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: Health Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: M004DS500
• Device Catalogue Number: M004DS500
• Device Lot Number: C8-09461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Received by Manufacturer: 11/02/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1