MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE RUNWAY GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number H74938969520

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

Patient Problem No Patient Involvement (2645)

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 a foreign matter was inside the sterile package.Upon receipt of the 6f runway fl3.5 sh guide catheter, a hair was noticed inside the sterile package while being taken out of the box.The sterile package was still closed.No patient involvement was reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Device analysis revealed that seal was broken; however, no damage was noticed on the outer packaging.The outer packaging was opened to inspect the sterile packaging inside.The sterile barrier had been opened down the entire side of the device exposing the inside packaging.Visual inspection showed no foreign material was present.No other issues or defects were observed during product analysis of the returned device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that a foreign matter was inside the sterile package.Upon receipt of the 6f runway fl3.5 sh guide catheter, a hair was noticed inside the sterile package while being taken out of the box.The sterile package was still closed.No patient involvement was reported.

• Brand Name: RUNWAY GUIDE CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer (Section G): AVAIL MEDICAL PRODUCTS INCORPORATED; 5950 nancy ridge drive; san diego CA 92121
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5865876
• MDR Text Key: 51770826
• Report Number: 2134265-2016-06943
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K033441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: H74938969520
• Device Catalogue Number: 38969-52
• Device Lot Number: 0050921282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2015
• 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