MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D134721IL

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.Upon receipt, the catheter was visually inspected and it was found pebax sleeve had deep scratches, no internals parts exposed.The returned device was then evaluated for electrical resistance and the thermocouple test failed.Further examination revealed that the thermocouple wires were broken at the tip section creating an intermittence of temperature.Additionally, a scanning electron microscope (sem) testing was performed on the pebax area and the results showed evidence of mechanical damage, and a hole on the pebax surface.Overlapping of the pebax material indicates that it has been torned apart.Object that cause the damage is unknown.No other anomalies were observed.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint has been verified.The tc failure is detectable in production, mitigating this failure from reaching the customer.This failure does not represent any patient safety impact.The root cause of the damage on the pebax 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 during the procedure, however, this cannot be conclusively determined.The customer also provided a photo of the catheter after reporting the temperature issues.According to pictures provided by customer, device packaging is observed.Photographs provided doesn't contain information related to the temperature issues reported, therefore, the customer complaint could not be confirmed from the pictures.(b)(6).Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter for which biosense webster¿s product analysis lab has identified a hole on the pebax.It was initially reported by the customer that during the atrial fibrillation (afib) operation, the temperature could not be displayed.A second catheter was used to complete the operation.There were no patient consequences.The customer¿s reported issue is not considered to be mdr reportable since the risk to the patient is low.On 10/3/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual inspection performed on 10/3/2019 revealed the pebax sleeve had deep scratches; no internals parts exposed.Surface scratches to the pebax sleeve that do not penetrate the pebax are not considered to be 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 11/4/2019, during further evaluation, a scanning electron microscope (sem) analysis was performed.Sem revealed there is integrity damage on the pebax as there is evidence of mechanical damage, and a hole on the pebax surface.Overlapping of the pebax material indicates that it has been torn apart.Object that cause the damage is unknown.No other anomalies were observed.These findings have been assessed as an mdr reportable malfunction since the integrity of the device is compromised.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through sem analysis on 11/4/2019 and reassessed this complaint as reportable.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION 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: 9394690
• MDR Text Key: 195390768
• Report Number: 2029046-2019-03929
• 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: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Catalogue Number: D134721IL
• Device Lot Number: 30216222L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Date Manufacturer Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2019
• 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