MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) WEBSTER FIXED CATHETER WITH AUTO ID; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number D-1085-413-S

Device Problems Entrapment of Device (1212); Knotted (1340)

Patient Problem No Code Available (3191)

Event Date 06/08/2017

Event Type  Injury  

Manufacturer Narrative

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.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.Concomitant products: bard medical 6fr sheath, model and lot numbers unknown; unspecified 14fr sheath.(b)(4).

Event Description

It was reported that a male patient, aged 50-70, underwent an ablation procedure for possible supraventricular tachycardia (svt) with a webster 4 pole with auto id catheter and suffered a medical device entrapment requiring surgical intervention.During the procedure, while maneuvering the webster his catheter into position, the catheter was inadvertently formed into a knot.Physician was unable to withdraw the catheter, as the knot was too large to pass through the 6 french sheath.At this point, no components of the catheter had become detached.Surgery and interventional radiology consults were conducted.After multiple attempts to remove the knot from the catheter, an interventional radiologist introduced a snare catheter into the left groin sheath, snared the distal end (near the tip), clipped the proximal end (near the handle), and pulled the catheter through the 14 french left groin sheath.Patient was reported to be in stable condition.Patient did not require extended hospitalization as a result of the adverse event.Patient fully recovered.It was noted that the arrhythmia was non-inducible and the procedure was terminated.Physician's opinion regarding the cause of the adverse event is that the catheter likely became stuck in a side branch and became knotted while being advanced forward.When the catheter was pulled through the sheath, it resulted in exposure of internal catheter components or sharp edges.

• Brand Name: WEBSTER FIXED CATHETER WITH AUTO ID
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 6681344
• MDR Text Key: 78905104
• Report Number: 9673241-2017-00549
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K892265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: D-1085-413-S
• Device Catalogue Number: D1085413
• Device Lot Number: 17629379M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2017
• Initial Date FDA Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/16/2017
• 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