MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN F/G RENEGADE 150/10/2TIP; CATHETER, CONTINUOUS FLUSH

Catalog Number	M001182570
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual and microscopic examination of the returned device revealed the catheter was separated on its proximal section.The catheter outer layer and inner braided tubing were also separated on its proximal section.The catheter was severely kinked, compressed, stretched and twisted on several places along its length.The catheter approximately distal 99.0 cm section was bent and compressed on several places along its length.The catheter proximal section was severely stretched.The renegade catheter outer layer was severely stretched and separated on several places along its proximal shaft length.The catheter inner braided tubings were severely stretched and still intact in middle section.From the condition (stretched, separated) of the catheter it appears to be gone under excessive force.Used during and/or after the use.Although this incident suggests that a 'handling error' occurred while using this product.An insufficient amount of information has been provided.Therefore, the exact cause for the observed catheter damages cannot be determined.
Event or Problem Description
Review of the investigation of the returned product revealed that the catheter shaft was fractured.There were no reported clinical consequences to the patient.

• Brand Name: F/G RENEGADE 150/10/2TIP
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 7733859
• Report Number: 3008853977-2018-00036
• Device Sequence Number: 11104039
• Product Code: KRA
• UDI-Device Identifier: 08714729301110
• UDI-Public: 08714729301110
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K973645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/30/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: M001182570
• Device Lot Number: 17096370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1