MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134701

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

The investigational analysis completed (b)(6) 2019.The returned device was inspected and reddish material was found in pebax sleeve.Then, during the second visual the reddish material in pebax sleeve was confirmed and a hole was found.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint was confirmed.The root cause of the damage on 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.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found a hole in the pebax.Initially, it was reported that there was blood inside the catheter tip.No external damage was reported.No adverse patient consequences were reported.The initially reported blood in the catheter tip was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The bwi pal received the device for evaluation on (b)(6) 2019.Upon initial visual inspection, reddish material was observed in the pebax, with no internal parts exposed.These findings coincide with what was initially reported.The observed reddish material in the pebax has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.Further testing was then performed.During a second visual inspection on (b)(6) 2019, the reddish material in the pebax was confirmed.Additionally, a hole was observed in the pebax.The observed hole in the pebax has been assessed as an mdr reportable malfunction, as the device integrity was compromised.The awareness date has been reset to (b)(6) 2019.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
• 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: 9507155
• MDR Text Key: 200012302
• Report Number: 2029046-2019-04046
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P030031
• 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: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1