MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133604IL

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that an unknown patient underwent a peripheral vascular case (arm)/ pvc (premature ventricular contraction) with a thermocool® smart touch¿ electrophysiology catheter.The pebax is broken.It was reported that during the pvc operation, the tip or splines of the catheter was found bent, wire was exposed.A second catheter was used to complete the operation.There was no adverse event reported on patient.Based on the photo attached the pebax appears broken.It is also unclear what procedure was done: the reporter states peripheral vascular case (arm) and pvc (premature ventricular contraction).Broken/cracked pebax is mdr-reportable.

Manufacturer Narrative

On 9-dec-2021, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.Summary: it was reported that an unknown patient underwent a peripheral vascular case (arm)/ pvc (premature ventricular contraction) with a thermocool® smart touch¿ electrophysiology catheter.The pebax is broken.Device evaluation details: according to pictures provided by the customer, the device was noted to be kinked at the tip section.There was also damage on the pebax resulting in exposed wiring.The product was returned to biosense webster for evaluation.Bwi then conducted a visual inspection of the returned device.The catheter was inspected and was found a hole at the pebax, reddish material inside it, and the tip bent.A manufacturing record evaluation was performed for the finished device 30607400m number, and no internal action was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; 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 dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12899769
• MDR Text Key: 282974940
• Report Number: 2029046-2021-02088
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2022
• Device Catalogue Number: D133604IL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• 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