MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THMCL SMTCH SF UNID, TC, F, IL; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D134722IL

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab (pal) received a picture on 11/5/2019.A picture evaluation was performed.However, no results could be obtained from it.Further investigation was performed once the device was returned.The investigational analysis for the device completed 1/10/2020.The device was visually inspected and reddish-brown material was found inside the pebax.Then, during the second inspection, a hole was observed on the pebax.The magnetic sensor functionality was tested on carto and the catheter was properly visualized.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.(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 sleeve.Initially, it was reported that during the procedure, the force was abnormal.Force values displayed high and the pressure value was not stable.A second catheter was used to complete the procedure.No adverse patient consequences were reported.The observed high force issues have 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.The bwi pal received the device for evaluation on 11/26/2019.Upon initial inspection, reddish-brown material was found in the pebax.The observed reddish-brown material has been assessed as not mdr reportable.Further testing was then performed.During a second inspection on 12/19/2019, the bwi pal observed a hole in the pebax sleeve.The observed hole in the pebax sleeve has been assessed as mdr reportable.The awareness date has been reset to 12/19/2019.

• Brand Name: THMCL SMTCH SF UNID, TC, F, IL
• 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: 9591599
• MDR Text Key: 200070559
• Report Number: 2029046-2020-00096
• 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: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2020
• Device Catalogue Number: D134722IL
• Device Lot Number: 30276732L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Date Manufacturer Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2019
• 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