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

Catalog Number	F5QD005RT
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Arrhythmia (1721); No Code Available (3191)
Date of Event	10/18/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7073132
• Report Number: 2029046-2017-01202
• Device Sequence Number: 1798265
• Product Code: LDF
• UDI-Device Identifier: 10846835007244
• UDI-Public: (01)10846835007244(11)170526(17)200430(10)17689891M
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K892265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: F5QD005RT
• Device Lot Number: 17689891M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 YR