MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133605IL

Device Problem Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.The customer had initially provided some pictures for evaluation.The pictures show that no temperature was observed on the stockert screen.From the pictures alone, the customer complaint was confirmed.The complaint product was later returned for evaluation.The device was visually inspected and it was found peek housing damage and electrode missing pu at the edge.Then, an electrical test and temperature features were tested and no issues were observed.The impedance was showed correctly.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.Based on product evaluation, the customer complaint cannot be confirmed.The root cause of the damage on peek housing and electrode cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device after of the procedure, however, this cannot be conclusively determined.(b)(6).(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab has identified a electrode damage.It was initially reported by the customer that during the af operation, the temperature could not be displayed.The second catheter was used to complete the operation.There were no patient consequence.This issue of ¿no temperature¿ is not mdr reportable since the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 1/13/2020, the bwi product analysis lab received the complaint device for evaluation.Initial visual inspection found no damage or anomalies.On 1/29/2020, during a second visual analysis the peek housing was observed dent and polyurethane (pu) is missing at the edge of the electrode #4.These findings were assessed as an mdr reportable malfunction.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on 1/29/2020 and reassessed the complaint as mdr reportable.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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: 9739545
• MDR Text Key: 200455451
• Report Number: 2029046-2020-00287
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Catalogue Number: D133605IL
• Device Lot Number: 30263603M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Date Manufacturer Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2019
• 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