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

Catalog Number D133604IL

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2020

Event Type  malfunction  

Manufacturer Narrative

The investigational analysis completed 5/8/2020.Pictures were returned by the customer that displayed high force values.The high pressure value was not stable.The device was visually inspected reddish material was found inside the pebax.During the second inspection, a hole was observed on the pebax.The magnetic sensor functionality was tested on carto.The catheter was properly visualized and no errors were observed.The force sensor feature was tested and it was working properly.The force values were observed within specifications.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint was not 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.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch¿ electrophysiology catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found a hole in the pebax.Initially, it was reported that force abnormal.It was reported that during the afib operation, the force values displayed are high/the pressure value was not stable, the second catheter was used to complete the operation.There was no report on adverse event on patient.The observed force issue 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.This event is being reported because the biosense webster inc.(bwi) product analysis lab (pal) received the device for evaluation and found.During a second inspection reddish material and a hole was found on the pebax.The observed hole has been assessed as an mdr reportable malfunction.The awareness date has been reset to 5/6/2020.

• 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: 10122137
• MDR Text Key: 195570723
• Report Number: 2029046-2020-00664
• 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: 03/23/2020

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 Expiration Date: 08/04/2020
• Device Catalogue Number: D133604IL
• Device Lot Number: 30265821M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 06/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2019
• 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