MAUDE Adverse Event Report: OSCOR INC. DESTINO STEERABLE GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	DS127122
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up report will be submitted as soon as the investigation is complete.
Event or Problem Description
It was reported the device was intact but the dilator was visibly shorter than the catheter shaft.Several trials were made on desk but the device resulted unusable.
Additional Manufacturer Narrative
H11: corrected data - h5 labeled for single use: yes.The device was used in treatment.Returned device analysis revealed the dilator was too short for the sheath.The dilator was fully inserted into the sheath and the dilator tip did not exit the distal tip of the sheath.It was confirmed that the sheath and dilator were both 12 french.The sheath measured correctly at 71cm, but the dilator measured incorrectly at 90.4cm.Although it cannot be confirmed, it is most probable that one of the 91cm dilators was inadvertently packaged with the 95cm lot and therefore was packaged with the incorrect sized sheath.The reason for return was confirmed.This issue is identified to be isolated and is the first occurrence known from the past 2 years.Both qa and manufacturing personnel were retrained to the area clearance procedure as well as their respective procedures that would prevent recurrence of this issue.Per procedure (area clearance): 4.1 area clearance must be performed before each new batch/lot of product to be processed and at the beginning of each shift.4.2.1 verify that the area is free of any materials that will not be used for the specific process.Including but not limited to all tables, bins, machines, tools, carts and/or others areas that could have remaining materials.Per manufacturing procedure (destino steerable guiding sheath and dilator packaging): 6.1 clear the packaging area from the items not used in the packaging process.Work on one model length and curve of a product at a time.6.2 prepare: product, bill of materials, work order, labels, destino packaging trays, the destino holding straps 1 & 2 and the tyvek pouches.Check the quantity of product to be packaged against work order.Verify the contents to be packaged match the bom.Verify quantity against the work order/traveler.Verify lot and model number on the inner tray label.6.6 match each dilator with each sheath by inserting dilator into distal end of sheath, up to the 3cm mark on the dilator, making sure to not puncture the seal.Verify there should be minimal gap between shaft and dilator at distal end.Then pack the matched dilator with that particular sheath.Wipe down the sheath and dilator with a clean dry polywipe.Per qa procedure (destino steerable guiding sheath packaging inspection): 6.1 inspect product one work order at a time to prevent mix-ups.6.2 proofread information on work order/traveler for completeness and accuracy.Verify the model number on the work order against the manufacturing codes.6.4 verify the contents of the package are matching with bom.Per instructions for use (ifu) destino steerable guiding sheath: 1.Select appropriate size of the sheath for the device to be delivered.2.Place a guidewire according to its own supplied instructions for use.3.Place dilator inside the sheath and lock both hubs together.Thread the dilator/sheath assembly over the guidewire, using a slight twisting motion.Personal awareness training has been conducted to prevent the recurrence of this issue.Based on the investigation, a capa is not required.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.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.
Additional Manufacturer Narrative
Corrected data from follow-up 1: section g7 was inadvertently listed as an update, however, is was section g6.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: DESTINO STEERABLE GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor, fl
• MDR Report Key: 10484751
• Report Number: 1035166-2020-00054
• Device Sequence Number: 13764590
• Product Code: DYB
• UDI-Device Identifier: 00885672000462
• UDI-Public: 00885672000462
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K120459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2021

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: 10/01/2022
• Device Model Number: DS127122
• Device Catalogue Number: DS127122
• Device Lot Number: C8-18006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 12/21/2020; 01/22/2021
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 01/19/2021; 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1