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

Model Number	M0066703091
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a sensor¿ guidewire was used in a procedure performed on (b)(6) 2018.According to the complainant, during preparation outside the patient, it was noticed that there was a foreign object at the tip of the sensor guidewire.The procedure was completed with a new sensor¿ guidewire.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported to boston scientific corporation that a sensor was used on a procedure performed on (b)(6) 2018.According to the complainant, during preparation, a foreign object was found at the tip of the sensor guidewire.There was no visible damage noted on the device and its packaging.The procedure was completed with a second sensor guidewire.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Correction as of (b)(6) 2018.There were no patient complications reported as a result of this event.Additional information received on july 30, 2018.Reportedly, there was no visible damage to the device packaging.
Additional Manufacturer Narrative
A visual assessment was performed.The device returned has no foreign matter.No visual defects were noted; the returned product looks under good conditions without evidence of damages or anomalies.The complaint is not consistent with the returned device that there was a foreign object at the tip of the sensor guidewire.The most probable cause for the complaint is not confirmed returned since the complaint included a returned device review (visual, physical, and performance testing) which showed no evidence of either the alleged issue or any defect which could have contributed to the event.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no similar complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation that a sensor was used on a procedure performed on (b)(6) 2018.According to the complainant, during preparation, a foreign object was found at the tip of the sensor guidewire.There was no visible damage noted on the device and its packaging.The procedure was completed with a second sensor guidewire.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Correction as of (b)(6) 2018.There were no patient complications reported as a result of this event.Additional information received on july 30, 2018.Reportedly, there was no visible damage to the device packaging.

• Brand Name: SENSOR¿
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7726349
• Report Number: 3005099803-2018-02345
• Device Sequence Number: 995994
• Product Code: EZB
• UDI-Device Identifier: 08714729257318
• UDI-Public: 08714729257318
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2020
• Device Model Number: M0066703091
• Device Catalogue Number: 670-309
• Device Lot Number: 20908007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 07/30/2018; 08/08/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 08/01/2018; 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1