MAUDE Adverse Event Report: BIOSENSE WEBSTER INC STOCKERT; SIMILAR DEVICE S7001, PMA # P990071

Catalog Number 39D76X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Additional clarification is being requested on the facility.However, no further information has been made available.If additional information is received regarding this facility and event, a supplemental 3500a report will be submitted to the fda.Concomitant product: thermocool smart touch bidirectional navigation catheter, us catalog #: d132705, lot #: unknown.(b)(4).

Event Description

It was reported that a (b)(6) year-old female patient underwent an atrial fibrillation (afib) ablation procedure with a stockert generator and suffered third burn degree requiring extended hospitalization.One week after a cardiac ablation procedure, the patient returned to the emergency room with a severe skin lesion in the lateral lumbar region probably caused by the adhesion region of the plaque of radiofrequency return.Extended hospitalization was required as a result of the adverse event.There's no information regarding additional medical/surgical intervention, patient¿s outcome or physician¿s causality opinion.Multiple attempts have been made to gain clarification on this event with no response.Should any new information be obtained, it will be assessed and processed accordingly.

Manufacturer Narrative

Investigation summary: it was reported that a (b)(6) female patient underwent an atrial fibrillation (afib) ablation procedure with a stockert generator and suffered third burn degree requiring extended hospitalization.One week after a cardiac ablation procedure, the patient returned to the emergency room with a severe skin lesion in the lateral lumbar region probably caused by the adhesion region of the plaque of radiofrequency return.Extended hospitalization was required as a result of the adverse event.There's no information regarding additional medical/surgical intervention, patient¿s outcome or physician¿s causality opinion.Repair follow-up was performed and device was not shipped for service.Service was declined.Complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device and no internal actions related to the reported complaint condition were identified.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On july 15, 2019, a correction was received on the manufactured date correcting the date from 6/6/2011 to 6/1/2011.Therefore, re-populated device manufacture date.Manufacturer's reference number: (b)(4).

• Brand Name: STOCKERT
• Type of Device: SIMILAR DEVICE S7001, PMA # P990071
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8450090
• MDR Text Key: 139793959
• Report Number: 2029046-2019-02873
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 39D76X
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/25/2019
• Supplement Dates Manufacturer Received: 07/15/2019; 07/17/2019
• Supplement Dates FDA Received: 07/16/2019; 07/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 37 YR