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

Model Number D-1282-08-S

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2017

Event Type  malfunction  

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.The device history record (dhr) for the lot number 17650855l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.(b)(4).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a pentaray navigational eco catheter.It was reported that the deflection mechanism of a pentaray catheter became broken during a procedure and the catheter curved into a loop.The catheter was removed and it stayed deflected.The ablation catheter was then used for mapping.The procedure was completed with no patient consequence.The response received on (b)(6) 2017 clarifies that the catheter may have been stuck in the fully deflected position.The piston could still be moved up and down.It just didn¿t fully unflex by doing so.The additional information provided on (b)(6) 2017, stating that the catheter may have been stuck in a fully deflected position was assessed as a reportable malfunction.Therefore, the awareness date is (b)(6) 2017.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 8/24/17.The device returned has a slight curve at the tip.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.The returned condition has been assessed as not reportable as the potential that it could cause or contribute to a death or serious injury, or other significant adverse event was remote.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a pentaray navigational eco catheter.It was reported that the deflection mechanism of a pentaray catheter became broken during a procedure and the catheter curved into a loop.The catheter was removed and it stayed deflected.The ablation catheter was then used for mapping.The procedure was completed with no patient consequence.The response received on august 1, 2017 clarifies that the catheter may have been stuck in the fully deflected position.The piston could still be moved up and down.It just didn't fully unflex by doing so.The returned device was visually inspected and it was found in normal conditions.Then per the event, a deflection test was performed and the catheter passed.Then, the catheter outer diameter was measured and it was found within specifications.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.The customer complaint cannot be confirmed.

• Brand Name: PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6773823
• MDR Text Key: 82897878
• Report Number: 9673241-2017-00623
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K123837
• 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,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: D-1282-08-S
• Device Catalogue Number: D128208
• Device Lot Number: 17650855L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2017
• Initial Date FDA Received: 08/08/2017
• Supplement Dates Manufacturer Received: 07/05/2017; 07/05/2017
• Supplement Dates FDA Received: 09/13/2017; 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2017
• 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