MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) LEVEEN¿ COACCESS¿; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number M001262230

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

Patient Problem Paralysis (1997)

Event Type  Injury  

Manufacturer Narrative

Journal article: palussie`re, jean et al, ¿retrospective review of thoracic neural damage during lung ablation ¿ what the interventional radiologist needs to know about neural thoracic anatomy¿, cardiovasc intervent radiol (2013) 36:1602¿1613, doi 10.1007/s00270-013-0597-z.Device evaluated by mfr: the device was not returned for analysis.The most probable root cause was unable to be determined.(b)(4).

Event Description

Reported via journal article.It was reported via journal article that radiofrequency ablation (rfa) was performed with a leveen electrode.A patient presented grade 2 temporary paresthesia on the medial side of the left forearm and in the fourth and fifth fingers after ablation of a recurrent metastasis in the superior lobe (apical).This tumor had been previously surgically resected, and surgical sequelae were present, thus preventing us from creating a pneumothorax.The treated tumor was situated 1 cm from the apical pleura.

• Brand Name: LEVEEN¿ COACCESS¿
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6961514
• MDR Text Key: 89718753
• Report Number: 2134265-2017-10063
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K012315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2017

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 Model Number: M001262230
• Device Catalogue Number: 26-223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2017
• Initial Date FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other