MAUDE Adverse Event Report: BIOSENSE WEBSTER INC FIX,5F,4P,D,5MM,10PN-DR,110; ELECTRODE, PACEMAKER, TEMPORARY

Catalog Number F5QD005RT

Device Problem Entrapment of Device (1212)

Patient Problems Arrhythmia (1721); No Code Available (3191)

Event Date 10/18/2017

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The device history record (dhr) for the lot number 17689891m has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Concomitant products: navistar catheter, us catalog #: ns7tcdl174hs, lot #: unknown; webster catheter, us catalog #: f5qd005rt, lot #: unknown.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a (b)(6) female patient underwent a cryoballoon ablation procedure for supraventricular tachycardia (svt) with webster catheters x 2 and suffered a medical device entrapment (requiring surgical intervention) and heart block.Fast anatomical mapping (fam) was performed with the navistar catheter.The coronary sinus catheter was positioned in the coronary sinus under fam and carto-univu guidance to reduce radiation exposure.Webster catheter # 1 was advanced through the inferior vena cava (ivc).While crossing the tricuspid annulus, webster catheter # 1 became entrapped.Attempts to free the catheter via manual maneuvers were unsuccessful.The proximal end (connector side) of webster catheter # 1 was cut off.A 7 french guiding catheter (brand-unspecified) was advanced over webster catheter # 1.Webster catheter # 1 and the 7 french guiding catheter were removed from the patient¿s body.Webster catheter # 2 was inserted, positioned in the right ventricle (rv), and the procedure continued.There were no injuries as a result of the medical device entrapment.It was noted that there was a 2-hour delay in the procedure.Later in the procedure, it was determined that the svt involved a para-hisian pathway.Physician concluded that the arrhythmia was untreatable due to atrioventricular block.The atrioventricular block was caused by the cryoablation during this procedure.The degree of the atrioventricular block and what interventions were performed in response to the atrioventricular block were not known.Remainder of procedure was aborted.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

Manufacturer Narrative

Additional information was received on june 4, 2018 stating that the product was discarded.Therefore, no product failure analysis can be conducted and device malfunction cannot be confirmed.The awareness date is june 4, 2018.Manufacturer's reference number: (b)(4).

• Brand Name: FIX,5F,4P,D,5MM,10PN-DR,110
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 949789-383
• MDR Report Key: 7073132
• MDR Text Key: 93422543
• Report Number: 2029046-2017-01202
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 10846835007244
• UDI-Public: (01)10846835007244(11)170526(17)200430(10)17689891M
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K892265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: F5QD005RT
• Device Lot Number: 17689891M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR