MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Model Number D-1327-00-S

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

Patient Problem Hematoma (1884)

Event Date 12/31/2015

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.Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.Concomitant products that used in this study: carto 3, cartomerge, lasso nav.Other company¿s devices that were used in this study: mullins.(b)(4).

Event Description

This complaint is from a literature source.It was reported that 178 patients (ai-group = 89 and cf group =89) with paroxysmal af underwent catheter ablation from january 2013 and december 2015 and were followed-up for 12 months.Among them, one patient had retroperitoneal hematoma in the cf group.Based on the facts of the case and the author¿s assessment, there were no reported malfunction with any of the bwi catheters and systems used during the case.Thus, this event is unrelated to the device and most likely related to the procedure.Title: ¿prospective use of ablation index targets improves clinical outcomes following ablation for atrial fibrillation.¿ ablation index (ai), a novel ablation quality marker, incorporates contact force (cf), time and power in a weighted formula.The purpose of this study was to determine whether the prospective use of previously-published derived ai targets would result in better outcomes when compared to cf-guided ablation.Suspect device is a thermocool smarttouch, however catalog and lot number is unknown.

Manufacturer Narrative

Additional information was obtained.It was reported one (b)(6) female patient with high bmi suffered retroperitoneal bleeding.The patient required extended hospitalization.The event did not result in the impairment of a body function or damage to a body structure and the patient was fully recovered.The author stated that bwi device cited in the article did not led to the reported patient consequences and the event was procedure related.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• 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: 6754961
• MDR Text Key: 81468513
• Report Number: 9673241-2017-00609
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

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 Model Number: D-1327-00-S
• Device Catalogue Number: D132700
• Device Lot Number: UNKNOWN_D-1327-00-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 07/31/2017
• Supplement Dates Manufacturer Received: 07/18/2017
• Supplement Dates FDA Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR