MAUDE Adverse Event Report: OSCOR INC. 10F ARRIVE BRAIDED TRANSSEPTAL SHEATH; INTRODUCER, CATHETER

Model Number	990061-070
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2015
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
Customer reported transseptal needle was scratching the inside of the dilator when it was introduced (with the guiding tool inside).Plastic particles were found after removal of the sheath.No patient symptoms or complications associated with this event.
Additional Manufacturer Narrative
According to the report, the transseptal needle was scratching the inside of the dilator when it was introduced with the guiding tool inside.Upon evaluation, it was found that the skiving was consistent with the diameter of the needle.Testing was also performed on new and used dilators to try to simulate skiving with a brockenbrough needle and two other competitor's needles.None of the dilators tested exhibited skiving.No transseptal needles are used at oscor during processing, assembly and inspection.Instead, a blunt inspection mandrel is used for insertion into the dilator shaft to check for patency on 100% of the dilators.The blunt mandrel used at oscor cannot cause skiving of this sort.There were no manufacturing rejects or anomalies recorded in the device history record.The sheath and dilator passed all in-process and qa final inspection steps at oscor before shipping to the customer including mandrel testing of the dilator for patency, visual inspection of the dilator, as well as the dimensional inspection.The potential causes of this failure include user does not use a stylet during transseptal use.The potential effects to the user may be prolonged surgical delay, intervention required to remove the detached material or serious injury if the piece of material was released into the patient's body.This failure is addressed in the instructions for use (ifu).Based on the investigation information, a capa is not required.Oscor will continue to monitor this device for complaint trends and risk.The qa adelante breezeway, in-process and final inspection procedure indicates that all products must meet the predetermined specifications in each step of this procedure.A roll test, is done on 100 percent of product.To verify there is no separation in transitions or any catheter segments roll the catheter 360° with a radius curve fixture.Inspect shaft for dents, bumps, cracks, wrinkles, kinks, exposed braid or marker bands, delamination or damage that may cause premature failure.Using a fiber optic light or microscope light to illuminate the inner diameter of the shaft, verify the presence of one marker band.The marker band must end before the start of the distal tip section.Verify the distal tip has a radius.Under 10x microscope using calipers the length of the distal tip is measured from the end of the bleed to the distal tip.The i.D.Of proximal end of catheter is measured with the o.D.Pin gauge and the i.D.Of distal tipped end is measured by inserting a pin gauge approximately 1 - 2 mm only into radius distal tip.The o.D.Of shaft is measured using a laser micrometer.Inspection for obstruction is inspected 100 percent by inserting a sample non-tipped dilator of appropriate size and length into shaft to assure inner lumen is free of any obstruct material.An inspection for hub over-molding is done on the first 5 good shots and 5 last shots of the lot.The hub is inspected for foreign material, cracks, sinking or unfilled areas.Hub should be smooth.Look inside the hub for irregularities or waviness.Verify presence of chamfer and roundness of parts.Look inside of the hub for any signs of delamination, exposed braid, or any damage to the shaft resulting from the over-molding process.A dimensional inspection is done of the sideport and the usable length from end of hub to end of sheath is measured.A pull test is done to check for bonding of tubing to the hub.Another inspection for obstruction is done by inserting a sample non-tipped dilator of appropriate size and length into over-molded sheath assembly to assure inner lumen is free of any obstruct material.Verify 2 holes 180° apart in distal tip.Ensure the holes are punched cleanly without damages or excess material obstructing the holes.A measurement of the flushport hole id by is taken by inserting a pin gauge under 10xb microscopes.A final sheath inspection is done by sampling plan ansi z 1.4, gen level i,normal, aql 0.40.The final inspection includes: with the naked eye, verify the shape and form of hub area.Verify that the hub is free of damages at the seal, bonded seal cap, hub, stopcock and sideport tubing.A leak test is performed.Test sideport for occlusion by attaching a 10 cc syringe with plunger completely pulled out to the open stopcock valve.Test both outlets of the stopcock, one at a time.Push and pull the plunger of the syringe to confirm air flow through sideport and tube.The instructions for use (ifu) cautions the user: prior to use, read all package inserts, warnings, precautions, and instructions.The procedure must be performed by trained medical personnel well versed in anatomical landmarks, safe technique, and potential complications.Potential adverse effects are included in the ifu: infection, thromboembolic events, local nerve damage, catheter entrapment, perforation, valve damage, dissection, pacemaker/defibrillator lead displacement, av fistula formation, air embolism, pseudoaneurysm formation, vasovagal reaction, or arrhythmias.The ifu cautions the user: never advance, torque, or withdraw sheath when resistance is met.Determine cause by fluoroscopy and then take remedial action.For transseptal use: follow the instructions for use that were supplied with the transseptal needle and the guidewire.If a transseptal needle is used, it is recommended to use together with a stylet in order to prevent skiving of the inner lumen of dilator.Wet the dilator shaft with sterile saline solution prior to insertion through the hemostatic valve.

• Brand Name: 10F ARRIVE BRAIDED TRANSSEPTAL SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 6301930
• Report Number: 1035166-2017-00011
• Device Sequence Number: 1102608
• Product Code: DYB
• UDI-Device Identifier: 00643169530591
• UDI-Public: 00643169530591
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2017

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: 09/01/2017
• Device Model Number: 990061-070
• Device Catalogue Number: 990061-070
• Device Lot Number: C1-09170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2015
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/15/2015
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 03/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1