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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Transient Ischemic Attack (2109); Vascular System (Circulation), Impaired (2572)

Event Date 11/01/2007

Event Type  Injury  

Manufacturer Narrative

Conclusion not yet available, evaluation in process.

Event Description

The literature publication reports the following patient complications while using a sheath catheter/ multi-electrode ablation catheter: there were six (6) patients who had "vascular injury"; there was one (1) patient, each, with reported sepsis and transient stroke.Per the author, the stroke was "related to an insufficient per-procedural anti-coagulation." multiple patients were noted in the article; however, a one to one correlation could not be made with unique lot numbers.The gender of the baseline characteristics is male and the baseline age is (b)(6) years old.The status/location of the sheath catheter/ablation catheter is unknown.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Additional information has been requested, however not received as of date of this report.A review of the device history record (dhr) review could not be performed as no specific lot numbers were provided.However inspection procedures require any oscor product pass all in-process and qa final inspection before shipping to the customer.Per the qa introducer sheath, adelante breezeway, in-process and final inspection procedure, the qa dimensional inspection is done 100 percent for distal tip length, shaft length, proximal end id, distal tipped end id, shaft od, sideport id (p/f), overmolded shaft length, hub id, flushport hole id and shaft od on the arrive sheath.If product does not comply with its specifications, it is rejected.In addition, qa inspection includes roll test of 100 percent, visual inspection of 100 percent for dents, bumps, cracks, wrinkles, kinks, exposed braid or marker bands, delamination or damage that may cause premature failure.Verify no separation between transitions of shaft, 100 percent inspection for obstruction to assure inner lumen is free of any obstruct material, a pull test is done to check for bonding of tubing to the hub, hole punching is inspected 100 percent and a leak test is done on all units in the instructions for use (ifu) it indicates regarding sheath handling: use extreme care when manipulating the sheath and/or dilator.Lack of careful attention can result in injury such as perforation or tamponade.Regarding the preparing and managing the transseptal sheath it states: assemble the dilator and sheath together until the dilator hub locks into the sheath hub.Also noted is the following: any device/component inserted through the hemostatic valve of the sheath should be wetted and placed through the center of the valve to prevent tearing of the seal and leakage.Back-bleeding - assure the stopcock is in the closed position after flushing to prevent back bleeding.Remove catheters and dilators slowly - remove devices from the sheath slowly.Rapid removal may damage the valve components resulting in blood flow through the valve and cause a vacuum allowing air to enter the sheath.Sideport aspiration - aspirate the sideport when withdrawing the catheter, probe, or dilator to remove fibrin deposits that may have accumulated in or on the tip of the sheath.Sideport infusion - infusion through the sideport and catheter should be done after all air is removed from the system.The devices were used in treatment.As the device was not returned, the allegations against these devices cannot be confirmed and root cause of the failures reported could not be determined.While multiple events were reported, none were correlated to specific product lots.Consequently, the manufacturer can neither verify failure nor determine potential causes of the failures.No further adverse events were reported as a result of the devices used in these procedures.Based on this investigation a capa is not required.

Event Description

The study involved had reviewed consecutive pvac procedures using the sheath catheter / multi electrode ablation catheter, in their centre, from november 2007 to december 2012.The original surgical procedures involved ablation strategy consisting of circumferential pulmonary vein isolation (cpvi) with the pvac system.Procedures were performed under conscious sedation.Venous access was obtained in the right femoral vein: a 10-pole catheter was placed in the coronary sinus, a single transseptal puncture was performed using an sl0 sheath and then exchanged for an arrive sheath for the pvac introduction.Seventy-seven patients were included with paroxysmal af.The mean duration of the procedure was 99.6 ± 26 min and fluoroscopy time 19.4 ± 6.8 min.Time of rfa was 22.4 ± 5.8 min.It was indicated that there were 77 total subjects in study; 50 males, 27 females.

Manufacturer Narrative

The following sections were corrected: the article did not mention or indicate that during this clinical study, any patient was in a life-threatening situation, this selection was deleted.The event description was not captured correctly; the article reported 8 patients with complications, not 7 as originally reported.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.

Event Description

The literature publication reports the following patient complications while using a sheath catheter/ multi-electrode ablation catheter: there were six (6) patients who had "vascular injury"; there was one (1) patient, with reported sepsis and 1 patient who experienced a transient stroke.Per the author, the stroke was "related to an insufficient per-procedural anti-coagulation." multiple patients were noted in the article; however, a one to one correlation could not be made with unique lot numbers.No lot numbers or other device identifiers were reported.The status/location of the arrive sheath's are unknown.No further patient complications have been reported as a result of this event.

• Brand Name: ARRIVE BRAIDED TRANSSEPTAL SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 de soto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 6682781
• MDR Text Key: 78897720
• Report Number: 1035166-2017-00055
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K122958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,literatur
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention