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

Model Number	DS127150GW
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint is part of internal retrospective review of complaints received from march 2014 to march 2016, conducted by oscor as a result of process improvements made to the complaint system to ensure proper medical device reporting is maintained.As part of the detailed review, this event has been determined to be reportable.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
On (b)(6) 2014 the customer reported "in patient #1, at the end of the case (with 2 insertions/retractions of the acm catheter) it was noted that a small ribbon fiber was present in the "basket" array area of the acm catheter.The fiber was disposed of at the clinical site.The sheath used in this case was returned to acutus medical for evaluation.The sheath was inspected on the outside and dissected to inspect the inside surface.No anomalies were found on the outside surfaces and observations were recorded regarding the inner surface (ptfe liner), some areas of the liner appeared to be scratched and/or not present.Some regions of the liner appear to have folds in the material.The sheath in question was model ds127150gw, l/n c8-01469.This was used in conjunction with an acm catheter.We are sending back the dissected parts and will await your findings.".
Additional Manufacturer Narrative
Returned device analysis reveals one 12f destino within manufacturing specifications.According to the report, some areas of the liner appeared to be scratched and/or not present and some areas of the liner appear to have folds in the material.Upon evaluation of the sheath, it was found that the handle was disassembled and one of the pull wires was broken.The shaft was cut up into nine different pieces.Two of the nine shaft pieces were cut longitudinally along the entire length, damaging the liner.The only area where the liner was actually damaged and/or scratched was along the longitudinal cut marks created by the customer.The liner inside the rest of the pieces looked smooth and no folds were found.Per procedure, a bore scope is used by qa on 100% of the sheaths to check for damage and delamination of the liner.There were no manufacturing rejects or anomalies recorded in the device history record.The sheath passed all in-process and qa final inspection steps before shipping to the customer including the bore scope testing, visual inspection of the sheath and dilator, as well as the dimensional inspection.No manufacturing defects were found.The reason for return cannot be confirmed.The potential effect to patient for the reported failure may be related to: cosmetic defects, production delay, rejected parts.Potential cause: unclean environment.A review of the risk for this failure mode identified that the risk as low.Based on the investigation information, a capa is not required.Oscor will continue to monitor this device for complaint trends and risk.Quality assurance procedure (destino steerable guiding sheath) in-process & final inspection: device is tested 100% using a bore scope to detect delamination of liner & any exposed braid in id.Instructions for use (ifu) instruct the user to use the steerable sheath only with compatible transvenous devices.Use the appropriate size sheath for the size of the transvenous device being utilized.Consequences of using the steerable sheath with incompatible devices may include the inability to deliver the transvenous device or damage to the transvenous device during delivery.

• Brand Name: 12 F DESTINO STEERABLE GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 6301794
• Report Number: 1035166-2017-00003
• Device Sequence Number: 1502625
• Product Code: DYB
• UDI-Device Identifier: 00885672001063
• UDI-Public: 00885672001063
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/07/2017

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: Physician
• Device Expiration Date: 07/01/2016
• Device Model Number: DS127150GW
• Device Catalogue Number: DS127150GW
• Device Lot Number: C8-01469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2014
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/12/2014
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 02/08/2017
• 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: ACM CATHETER