MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH MEDIUM; INTRODUCER, CATHETER

Model Number D138502

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2021

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 4/16/2021.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a (b)(6)-year-old male patient (>400 pounds) with history of congenital heart defect fixed and an uncorrected right to left intra atrial patent foramen ovale underwent an atrial flutter (afl) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium on which a medical device entrapment occurred requiring surgical intervention.The patient had a medtronic dual pacemaker in place and the pacemaker was appropriately interrogated and parameters checked with surgeon prior to, during and post procedure.The patient was brought to the lab where a transesophageal echocardiogram (tee) was performed after patient was intubated.The patient fraction of inspired oxygen (fi02) was at 100% but blood 02 levels were constantly at 82%.This was noted by the anesthesiologist and to both the electrophysiologist and cardiologist who performed the tee.During the procedure, the physician proceeded to gain right femoral access using a 7cm 18-gauge needle and vascular ultrasound.Due to thickness of size, access was obtained in the right femoral region.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was then inserted and pre-dilated with an 8fr.11cm sheath.After pre-dilation, surgeon inserted the vizigo over a wire and into the patient¿s groin which was believed to be in the right femoral vein (rfv).The patient's blood oxygen saturation dropped from 100% initially to approximately 80%.No intervention was done.Blood return was a dark blood and non-pulsatile from the needle.Ultrasound was used to assist with femoral access.The physician stated that there was some resistance when the sheath was advanced.A second access was achieved using the short 8fr.Sheath with selinger technique.The physician gained vessel access and inserted the pentaray nav catheter via the 8fr.Sheath in the rfv and a fast anatomical mapping (fam) of the right atrium (ra) was obtained.The stsf ablation catheter was then advanced through the vizigo.When inserting, it was noticed as soon as they made it to the level of the low ra that the ablation was in a more posterior path than the inferior vena cava (ivc) was, it was quickly identified that the ablation catheter via the vizigo was not in the rfv but had been placed in the patient¿s aortia/illiac artery.The staff worked to set up a pressure line.The physician did not ever advance the sheath above the coronary sinus (cs) region of the ra geometry.Later he said (post procedure and complication resolution) that there was some resistance noted when inserting the stsf catheter.He did not force or explore what might be the issue.This case was performed without fluoroscopy or xray up to this point.The physician then asked for an agilis sheath.This was placed in the rfv using vascular ultrasound.Due to the patient¿s low o2 saturation, the physician decided that he was not going to utilize a cs but do a simple cavotricuspid isthmus (cti) ablation to resolve the flutter.They entrained the flutter at a rate of 230 for a flutter cycle length (cl) of 256ms with the stsf catheter in the agilis nxt sheath.Ablation was done at 50 watts with the impedance around 110-155 ohms for the entire procedure.The flutter terminated after extending from 256 to 282 then an abrupt termination where he was in an atrial paced rhythm.The physician did not want to insert a cs or another catheter in the body to check for bidirectional block.At this point, he set the pacemaker with appropriate parameters, we proceeded to check for our baseline intervals, a-h, hv and qrs duration.When looking under fluoroscopy to see if the abbott preclose device might be adequate to close the arterial sheath in this patient, while attempting to withdraw the vizigo sheath, the physician felt some resistance from his attempting to remove the sheath.Fluoroscopy was used, and it was noted in an anterior-posterior (ap) right anterior oblique (rao) view of 30 degrees that the distal portion of the vizigo near the 4th electrode was indeed kinked back upon itself.The wire braiding was compressed between the proximal 4th and 3rd electrode.There was visible kinking of the braided material.There was no puncture or external break from the catheter/sheath lumen.The physician attempted to insert the smarttouch catheter to the vizigo to attempt to straighten but this was unsuccessful.Vascular surgery was then called to assist with removal of the vizigo sheath, the sheath was able to be accessed using an 0.35 amplatz wire.The wire allowed the sheath to be withdrawn from the lower descending aorta to the aorto-illiac junction where the catheter was able to relax and resume a more natural state.The vizigo was exchanged over the amplatz wire for a 10fr 11cm sheath and the wire was removed.At this point the performing surgeon decided to do a double abbott perclose deployment system with the abbott representative.No injury to the patient.The patient achieved hemostasis, manual pressure to venous access was achieved as well as surgical perclose to the arterial system.Patient was not part of a clinical study.No further complication was reported.Patient was a&ox4 (alert and oriented) by the time he was transferred out on the hospital (b)(6) in a slight semi-fowlers position with a cathlab rn continuing to support pressure to the patients right groin.There was nothing wrong with the vizigo hemostatic valve, blood aspiration and flushing was able to be achieved with the hemostatic valve working properly during the entire event.Pentaray and smarttouch sf catheters were found to be in operational condition and were not related to the issue.The issue with the distal part of the device was assessed as not mdr reportable for a tip bent/twisted issue.If the tip of the device is bent/twisted; however, no internal components are exposed, then it is not reportable.The medical device entrapment was assessed as a mdr reportable malfunction which required surgical intervention.

Manufacturer Narrative

During the device evaluation at the biosense webster, inc.Product analysis lab, it was observed on 5/21/2021 that the tip was damaged, bent, twisted and had wires exposed.The additional condition of the wires exposed was assessed as mdr reportable.The awareness date for this additional reportable lab finding is 5/21/2021.Therefore, added "h6.Medical device problem code" of "detachment of device or device component (a0501)".If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a 36-year-old male patient (>400 pounds) with history of congenital heart defect fixed and an uncorrected right to left intra atrial patent foramen ovale underwent an atrial flutter (afl) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium on which a medical device entrapment occurred requiring surgical intervention.Fluoroscopy was used, and it was noted in an anterior-posterior (ap) right anterior oblique (rao) view of 30 degrees that the distal portion of the vizigo near the 4th electrode was indeed kinked back upon itself.The wire braiding was compressed between the proximal 4th and 3rd electrode.There was visible kinking of the braided material.The device evaluation was completed on 31-aug-2021.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and an evaluation of all features of the catheter.Visual analysis revealed that the tip was damaged.It was bent, twisted and it had wires exposed.The issue could be related to excessive force or manipulation; however, this cannot be conclusively determined.Per the event, several tests were performed.The carto 3 and electrical features were tested and no issues were observed.In addition, the device was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A device history record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The instructions for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.Explanation of codes: -investigation findings: mechanical problem identified (c07)/ investigation conclusions: cause not established (d15) /component code: tip (g04129) were selected as related to the customer¿s reported ¿broken tip¿ issue.Investigation findings: no device problem found (c19)/ investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported adverse event issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH MEDIUM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11703822
• MDR Text Key: 247480811
• Report Number: 2029046-2021-00622
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/21/2021
• Supplement Dates Manufacturer Received: 05/21/2021; 08/31/2021
• Supplement Dates FDA Received: 06/12/2021; 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON BWI AGILIS SHEATH.; PENTARAY NAV ECO 7FR, F, 4-4-4.; SMARTTOUCH CATHETER.; THMCL SMTCH SF BID, TC, F-J.; UNKNOWN BRAND 0.35 AMPLATZ WIRE.; UNKNOWN BRAND 7CM 18-GAUGE NEEDLE.; UNKNOWN BRAND8FR. 11CM SHEATH.
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR