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

Catalog Number D128211

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 10/04/2018

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.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.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.(b)(4).Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent a procedure with a pentaray nav high-density mapping eco catheter and a medical device entrapment requiring excessive manipulation occurred.The catheter tips (spines) became detached and dislodged into the patient¿s body.This event is mdr reportable.During the mapping phase of the atrial tachycardia in the left atrium, it was reported that the spines of pentaray nav high-density mapping eco catheter got caught in a prosthetic valve causing it to temporarily cease functioning.The doctor decided to pull the catheter from the patient¿s body and discovered that two spines, including the electrodes were broken off and remained in the patient¿s body.One of the pieces was in the descending aorta and one in the intercostal artery.A snare was used to remove both pieces.There were no patient consequences and it was confirmed that no items remained in the patient.After that, the procedure continued, ablation was conducted for the atrial tachycardia and procedure was completed.The patient was reported to be in stable condition with no abnormalities.Per the instructions for use of the pentaray¿ catheters, under the contraindications section, "do not use pentaray¿ catheters in patients with prosthetic valves." the physician commented that he knew that the pentaray nav eco¿s use for prosthetic valve was a contraindication, he had heard the announcement before but had forgotten.Since it is also described in the package insert, it is the responsibility of the doctor.In the future, they will not ablate patients with prosthetic valves.The issue of spines breaking off from the catheter and the issue of excessive catheter manipulation to retract the catheter are considered mdr reportable malfunctions.

Manufacturer Narrative

On 11/8/2018, additional information about the patient and event were received.It was confirmed that no patient consequence occurred after the procedure and surgical intervention was required to remove the entrapped spines.Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

On 1/16/2019, additional information was received indicating the lot number of the involved device is 30072104l.On 1/25/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis found that ¿2 of the splines have wires exposed.¿ the findings have been assessed as mdr reportable malfunctions.Device evaluation details: it was reported that a patient underwent a procedure with a pentaray nav high-density mapping eco catheter and a medical device entrapment requiring excessive manipulation occurred.The catheter tips (spines) became detached and dislodged into the patient¿s body.During the mapping phase of the atrial tachycardia in the left atrium, it was reported that the spines of pentaray nav high-density mapping eco catheter got caught in a prosthetic valve causing it to temporarily cease functioning.The doctor decided to pull the catheter from the patient¿s body and discovered that two spines, including the electrodes were broken off and remained in the patient¿s body.One of the pieces was in the descending aorta and one in the intercostal artery.A snare was used to remove both pieces.There were no patient consequences and it was confirmed that no items remained in the patient.The device evaluation has been completed.The device was inspected and two splines were observed broken and with internal parts exposed.As such, the customer complaint is confirmed.The root cause of the spline detached could be related to the procedure, since the instructions for use state that the pentaray¿ catheters should not be use in patients with prosthetic valves.In addition, the physician commented that he knew that the pentaray nav eco¿s use for prosthetic valve was a contraindication, he had heard the announcement before but forgotten.Since it is also described in the package insert, it is the responsibility of the doctor.In the future, we will not ablate patients to prosthetic valves.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.Manufacturer¿s ref # (b)(4).

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO 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: 8024944
• MDR Text Key: 125676946
• Report Number: 2029046-2018-02233
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2021
• Device Catalogue Number: D128211
• Device Lot Number: 30072104L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention