MAUDE Adverse Event Report: LAKE REGION MEDICAL (DISTRIBUTED BY BOSTON SCIENTIFIC) ZIPWIRE STANDARD HYDROPHILIC GUIDEWIRE; ZIPWIRE HYDROPHILIC GUIDEWIRE

Catalog Number M006630205BO

Device Problems Material Fragmentation (1261); Failure to Advance (2524)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/08/2016

Event Type  malfunction  

Event Description

Patient undergoing portacath insertion in operating room.Surgeon unable to thread guidewire down dilator, another guidewire used.Unable to thread 2nd guidewire and procedure aborted.Patient to di interventional radiology where radiologist discovered two foreign bodies (fb): one in the superior vena cava (svc), the other in a segmental branch of the pulmonary artery (pa).Foreign bodies appear to be coating from guidewire.Fb in svc removed.Other fb in pa not removed.Portacath inserted successfully by radiologist.

• Brand Name: ZIPWIRE STANDARD HYDROPHILIC GUIDEWIRE
• Type of Device: ZIPWIRE HYDROPHILIC GUIDEWIRE
• Manufacturer (Section D): LAKE REGION MEDICAL (DISTRIBUTED BY BOSTON SCIENTIFIC); 340 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 6105630
• MDR Text Key: 60042785
• Report Number: 6105630
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2016

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: Physician
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: M006630205BO
• Device Lot Number: 10720230
• Other Device ID Number: GTIN 08714729761716
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: N/A.