MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. PENTARAY NAV HIGH-DENSITY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number UNK_PENTARAY

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

Patient Problem Cardiac Tamponade (2226)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref # (b)(4).

Event Description

It was reported that a (b)(6)-year-old female patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a pentaray catheter and suffered cardiac tamponade requiring pericardiocentesis.After going transseptal, the pentaray catheter was used to map, then was replaced with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) which was placed in the left ventricle (lv).The stsf seemed further than the shell of the lv on the map.Pericardial effusion was discovered; however, it¿s cause is unknown.Cardiac tamponade was diagnosed via intracardiac ultrasound (ice).Pericardiocentesis was performed to drain an unspecified amount of fluid from the pericardial space.The patient was reported in stable condition after pericardial drainage.No radiofrequency (rf) was delivered prior to the tamponade.The physician does not believe the perforation occurred in the lv as the blood that was drained was dark red and he felt it comes from the right atrium (ra), he did not believe the event was caused by a product malfunction but probably occurred when positioning the pentaray catheter or while maneuvering the acunav catheter for views.With the information available, this event is being coded and reported under the pentaray catheter as it seems that the perforation occurred in the ra while maneuvering the diagnostic and acunav catheters.Per physician¿s opinion, the perforation did not occur in the lv where the stsf catheter was placed; in addition, no rf was delivered and therefore, the stsf can be excluded.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).On 3/15/2021, it was noticed that the following information was inadvertently omitted from section h10.10.Additional manufacturer narrative of the 3500a initila medwatch report: "additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer." additionally, the following fields were also incorrect, and the following corrections have been processed: h6.Method code 4118 (type of investigation not yet determined) should have been 4114 (device not returned).H6.Results code 3233 (results pending completion of investigation) should have been 3221 (no findings available).H6.Conclusions 11 (conclusion not yet available) should have been 4315 (cause not established).

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10204170
• MDR Text Key: 198871318
• Report Number: 2029046-2020-00769
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_PENTARAY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THMCL SMTCH SF BID, TC, D-F; UNK_ACUNAV
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR