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 Problems Material Too Rigid or Stiff (1544); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 05/01/2017

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Biosense webster manufacturer's ref.No.'s (b)(4) are related to the same incident.(b)(4).

Event Description

It was reported that there were ten smart touch bidirectional catheters tips retrieved from the past few weeks which had the tips cut off after their procedures.While manually feeling the tips, they were believed to have ¿sharp¿ edges as they were not as smooth as expected.They also noted that the area on the catheter tip which got caught under the reported manufacturer reference number (b)(4) correlates with the area of roughness on some of these catheter tips.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.This issue has been assessed as a reportable malfunction.If an electrode ring edge appears to be sharp or rough, then this may cause damage to vascular endothelial linings during the withdrawal of the catheter and sheath.

Manufacturer Narrative

Notified by the biosense webster failure analysis lab that the device was received for evaluation on june 27, 2017.The device was returned in the condition reported as only the catheter tip was returned.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.(b)(4).

Manufacturer Narrative

Manufacturer's ref no: (b)(4).It was reported that there were ten smart touch bidirectional catheters tips retrieved from the past few weeks which had the tips cut off after their procedures.While manually feeling the tips, they were believed to have ¿sharp¿ edges as they were not as smooth as expected.They also noted that the area on the catheter tip which got caught under the reported manufacturer reference number (b)(4) correlates with the area of roughness on some of these catheter tips.The returned device was only the tip.No sharp edges were observed.The catheter outer diameter was measured and it was found within specification.A meeting with the manufacturing team was performed to investigate this issue and it was concluded that it is not related to the manufacturer process.The device history record (dhr) could not be reviewed since the lot is not available.The customer complaint cannot be confirmed.

• 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: 6613593
• MDR Text Key: 76866769
• Report Number: 9673241-2017-00433
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1