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

Model Number M00556531

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

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 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.

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 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¿
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-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: 6979274
• MDR Text Key: 90963171
• Report Number: 3005099803-2017-03267
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 08714729874515
• UDI-Public: 08714729874515
• Combination Product (y/n): N
• PMA/PMN Number: K141820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 10/26/2017
• Supplement Dates Manufacturer Received: 11/03/2017
• Supplement Dates FDA Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1