MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE RUBICON¿ 35; CATHETER, PERCUTANEOUS

Model Number H74939240035131

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

Patient Problem No Patient Involvement (2645)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the device sterility was compromised.A rubicon¿ 35 was selected for use.During unpacking, it was noted that there was a short hair strand inside the sterile packaging of the device.The product was not used in any procedure.No patient complications were reported and the patient's condition was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Returned device consisted of a rubicon 35 support catheter in the sterile unopened pouch.The device sterile pouch was visually inspected for any damage or irregularities.No damage was noticed on the packaging.Visual analysis did not show any foreign matter through the pouch as returned.The pouch was opened to inspect the contents where a hair was noticed on the sterile pouch material.The quality engineer was notified and viewed the product and confirmed the foreign matter inside the pouch.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is manufacturing execution error as the manufacturing process was not executed as validated/as designed.(b)(4).

Event Description

It was reported that the device sterility was compromised.A rubicon¿ 35 was selected for use.During unpacking, it was noted that there was a short hair strand inside the sterile packaging of the device.The product was not used in any procedure.No patient complications were reported and the patient's condition was stable.

• Brand Name: RUBICON¿ 35
• 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: 7161520
• MDR Text Key: 96383819
• Report Number: 2134265-2017-12939
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K122394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2020
• Device Model Number: H74939240035131
• Device Catalogue Number: 39240-03513
• Device Lot Number: 0020735915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2017
• 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