MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ESP¿; GLOVE, PATIENT EXAMINATION, SPECIALTY

Model Number M0067051041

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was not received for analysis.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).

Event Description

I was reported that when using the esp¿ specialty gloves, the physician would have to use multiple pairs during a procedure due to tearing at the seams.No patient or provider complications were reported.

• Brand Name: ESP¿
• Type of Device: GLOVE, PATIENT EXAMINATION, SPECIALTY
• 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: 7486996
• MDR Text Key: 107352548
• Report Number: 3005099803-2018-01293
• Device Sequence Number: 1
• Product Code: LZC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K891968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0067051041
• Device Catalogue Number: 705-104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2018
• 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: Initial
• Patient Sequence Number: 1