MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) JAGWIRE¿; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	M00556561
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two unused guidewires were returned for analysis.The devices were received in a sealed pouch, the sterile barrier is intact in both of them.Visual examination revealed that there was a foreign material inside one of the pouches.The complaint is not consistent with the outer shipping carton had dust as it was not returned however it was found that the foreign material was inside the guidewire sterile pouch.Based on all gathered information, the most probable root cause is manufacturing-execution error.An investigation has been initiated to address this issue.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 jagwire guidewire was unpacked.According to the complainant, during unpacking, there were a lot of dust seen inside the outer shipping box, not inside the pouch.There was no procedure involved and the device was not used in the patient.Investigation results revealed on (b)(6) 2017 that there was a foreign material inside one of the pouches.

• Brand Name: JAGWIRE¿
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7135479
• Report Number: 3005099803-2017-03856
• Device Sequence Number: 1310506
• Product Code: OCY
• UDI-Device Identifier: 08714729501374
• UDI-Public: 08714729501374
• Combination Product (Y/N): N
• PMA/510(K) Number: K141820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2017

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: M00556561
• Device Catalogue Number: 5656
• Device Lot Number: 20904618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1