MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) SENSOR¿; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number M0066703051

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a sensor guidewire was to be used during a procedure.Procedure date is unknown.According to the complainant, when the sensorwire guidewire was unpacked during preparation, it was noted the introducer tip of the hoop was dirty.Reportedly, this was inside the sterile packaging.The procedure was completed with another sensor guidewire.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

A visual evaluation of the returned guidewire, which was loaded in the hoop, there were spots found on the distal tip of the packaging hoop.The complaint is consistent with the returned device since the packaging hoop tip had foreign matter on it.Based on all gathered information, the investigation fails to determine a definite root cause.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database revealed that no other complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a sensor guidewire was to be used during a procedure.Procedure date is unknown.According to the complainant, when the sensorwire guidewire was unpacked during preparation, it was noted the introducer tip of the hoop was dirty.Reportedly, this was inside the sterile packaging.The procedure was completed with another sensor guidewire.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

• Brand Name: SENSOR¿
• Type of Device: STYLET FOR CATHETER, GASTRO-UROLOGY
• 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: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5463677
• MDR Text Key: 39205942
• Report Number: 3005099803-2016-00458
• Device Sequence Number: 1
• Product Code: EZB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2018
• Device Model Number: M0066703051
• Device Catalogue Number: 670-305
• Device Lot Number: 18339019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2015
• 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