MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D132705

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

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 02/20/2019

Event Type  Death  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.As such the investigation will be closed.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Concomitant product: decanav electrophysiology catheter (us catalog # r7d282ct, lot # unknown).(b)(4).

Event Description

It was reported that a (b)(6)-year-old male patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and suffered retroperitoneal bleeding that led to patient¿s death.The ablation site was really close to the aortic valve on the left atrium.The physician performed two punctures: one venous (to explore the right atrium at first) and one arterial to have better stability for the ablation right below the aortic valve.At the end of the procedure, the catheters were already outside the body, the physician performed the arterial closure with perclose suture.Few minutes after the closure, the vital and physiological parameters dropped down.Ultrasound was performed and there was no pericardial effusion/tamponade/perforation.Brain and abdomen x-rays were performed, and retroperitoneal bleeding was confirmed.The bleeding was described as a large blood leakage and the patient posteriorly died.No bwi product malfunctions were reported during the case.Physician¿s opinion regarding the cause of the death is that it was related to the arterial closure.The physician did not attribute the causality of the adverse event to any bwi product.

Manufacturer Narrative

On 3/15/2019, additional information was received confirming the sheath used in this procedure was a non-bwi sheath.On 3/25/2019, additional information was received listing the following medications as administered to patient during the procedure: dormicum : 2 mg iv at 12:52.Heparine: 2000 ul iv at 13:00.Naci 0.9% 500 ml : 500 ml/h perfusion iv at 13:02.Naci 0.9% 2000 ml : 2000 ml/h perfusion iv at 13:03.Carbostesin 0.25 % : 20 ml souscut at 13:03.Serum heparine : 500 ml iv at 13:05.Heparine : 7000 ul iv at 13:25.Heparine : 1000 ul iv at 14:01.Protamine : 5000 ul iv at 15:15.Atropine : 0,5 mg iv at 15:43.Ephedrine : 10 mg iv at 15:43.Naci 0.9% 500 ml : 500 ml/h perfusion iv at 15:50.Atropine : 0,5 mg iv at 16:03.Ephedrine: 10 mg iv at 16:03.Naci 0.9% 500 ml : 500 ml/h perfusion iv at 16:05.On 3/25/2019, the product details for the thermocool® smart touch¿ bi-directional navigation catheter were received as us catalog # d132705; lot# 30133696m.The respective fields in section d.Suspect medical device have been populated.On 3/25/2019, additional information received lists the following products as concomitant products used during the procedure: concomitant bwi products: smartablate irr tube set (us catalog # sat001, lot # ac4480182).Decanav electrophysiology catheter (us catalog # r7f282ct, lot # 30131251m).Carto3 external refpatch 6pack (qty 2) (us catalog # crefp6, serial # ll017488).Concomitant non-bwi products: lntro a/guide metal courbe 7f 035 l.10cm radifocus ii pce (autre) w wm31- ref.: 467373- code produit: 467373.Electrode ecg surveillance ad.Rxtransp.Red dot 3m 2570 1x50 (autre) w inconnu- ref.: 119021 - code produit: 119021.Electrode p/def.Fr2 multfction adu.Heartstream philips 1x1 0 (autre) w 829866- ref.: 442011 -code produit: 442011.Lntroducteur a/guide 8f ang l 25cm radifocus pee (autre) w 170824a- ref.: 27722- code produit:27722.Set hemostat.Vasc.6f perclose proglide avo pee (autre) w 8120541- ref.: 466720- code produit: 466720.Set hemostat.Vasc.6f perclose proglide avo pee (autre) w 8120541- ref.: 466720- code produit: 466720.Set hemostat.Vasc.6f perclose proglide avo pee (autre) w 8120541917772- ref.: 466720- code produit: 466720.Set hemostat.Vasc.6f perclose proglide avo pee (autre) w 8120541917766- ref.: 466720-code produit: 466720.Guide wire 035 j l.175cm ptfe emerald cordis pee (autre) w 35236158- ref.: 462609- code produit: 462609.Ceinture p/compression cardio angio h15cm tale pee (autre) w inconnu- ref.: 7612677900045 - code produit: 426767.Champs a/mat.P/coro.Cardiva vascular medical pee (autre) w 201879946- ref.:8429659018723- code produit: 425414.Lntro a/guide metal courbe 8f 038 l.10cm radifocus pce (autre) w wn07- ref.: 461980 ¿ code produit: 461980.Probe cover kit 14x121.9 em pull up protek pee (autre) w 73575- ref.: 2097 - code produit: 435739.Also, a manufacturing record evaluation was performed for the finished device 30133696m number, and no internal actions were found during the review.Manufacturer¿s ref # (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8418923
• MDR Text Key: 138752561
• Report Number: 2029046-2019-02802
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2019
• Device Catalogue Number: D132705
• Device Lot Number: 30133696M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 78 YR