MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).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.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.  information regarding patient weight, height, medical history, race, and ethnicity was not reported.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿acute fluctuating neurological deficits after pulmonary vein isolation: unmasking a rare complication due to spontaneous spinal subdural bleeding: a case report.¿ a (b)(6) year-old woman with a 2-year history of highly symptomatic paroxysmal af (ehra 3) was referred for a pvi redo procedure.A high-density mapping showed pulmonary vein reconnection of all pulmonary veins successfully isolated by radiofrequency ablation.During the entire procedure, the patient had sinus rhythm with an act around 300 s.No intraprocedural and peri-procedural complications occurred.Four hours after hemostasis, the anticoagulation clotting time (act) was 110 s, and rivaroxaban (20 mg) was reinitiated.In the following hours, the patient developed fluctuating neurological lower limb symptoms.A lumbar magnetic resonance imaging showed a subdural spinal haematic collection with an associated epidural component from l3 to s2 exerting compression over the dural sheath.A conservative treatment approach was adopted with the progressive recovery of sensorial and motor deficits.After 5 months, the patient still presented residual lower limb motor deficits necessitating the support of a walking stick.A radiofrequency ablation catheter (thermocool smarttouch, inc., irvine, ca, usa) was performed.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10163382
• MDR Text Key: 195539874
• Report Number: 2029046-2020-00711
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/27/2020

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 Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR