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

Model Number	M00556531
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported to boston scientific corporation that a jagwire guidewire was unpacked.According to the complainant, during unpacking, there was a foreign object which seemed like a hair found inside the package of this device.There was no procedure involved and the device was not used in the patient.
Additional Manufacturer Narrative
Visual examination revealed that the guidewire was received in a sealed pouch, the sterile barrier was intact.The visual assessment identified a hair inside the pouch.In addition, there were three additional foreign material fragments that were loose inside the pouch.The complaint is consistent with the returned guidewire that there was a hair inside the pouch.Based on all gathered information, the most probable root cause is ¿manufacturing.¿ 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 was a foreign object which seemed like a hair found inside the package of this device.There was no procedure involved and the device was not used in the patient.

• 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: 6979274
• Report Number: 3005099803-2017-03267
• Device Sequence Number: 1197276
• Product Code: OCY
• UDI-Device Identifier: 08714729874515
• UDI-Public: 08714729874515
• 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,Followup
• Report Date (Section B): 10/05/2017

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: 08/15/2020
• Device Model Number: M00556531
• Device Catalogue Number: 5653
• Device Lot Number: 21020048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1