MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE GUIDEZILLA¿; CATHETER, PERCUTANEOUS

Model Number H7493924215050

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

Patient Problem No Patient Involvement (2645)

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device has not been received for analysis.Upon receipt and 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.(b)(4).

Event Description

It was reported that foreign matter was observed in the outer box of the device.A guidezilla¿ guide extension catheter was selected for use.During unpacking, it was noted that there was something like blood found in the outer box of the device.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Returned device consisted of a guidezilla guide extension catheter in the box.The box was visually inspected.Inspection revealed a small area on the backside of the carton that was a reddish-brown mark.Inspection found the remainder of the device free of damage.The device and the foreign matter (fm) were sent for testing to confirm the presence of blood.Testing did not give a conclusive result as to the source of the fm, but did confirm general fm on the box.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that foreign matter was observed in the outer box of the device.A guidezilla¿ guide extension catheter was selected for use.During unpacking, it was noted that there was something like blood found in the outer box of the device.There were no patient complications reported.

• Brand Name: GUIDEZILLA¿
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6807491
• MDR Text Key: 83143362
• Report Number: 2134265-2017-08184
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K123765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2017

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: 12/31/2017
• Device Model Number: H7493924215050
• Device Catalogue Number: 39242-1505
• Device Lot Number: 18758212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 08/21/2017
• Supplement Dates Manufacturer Received: 10/16/2017
• Supplement Dates FDA Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1