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

Catalog Number	M001182570
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that when the guidewire was advanced in the microcatheter (subject device), the guidewire perforated between the two tips of the microcatheter, causing a hole.The physician replaced it with a new microcatheter and completed the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that when the guidewire was advanced in the microcatheter (subject device), the guidewire perforated between the two tips of the microcatheter, causing a hole.The physician replaced it with a new microcatheter and completed the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual inspection revealed that the catheter shaft was noted to be flattened in 2 locations between the proximal and distal marker bands.No other anomalies were noted.During functional testing, the device was flushed with a valve attached to the distal end and no leaks were noted.The reported hole/perforation could not be confirmed during analysis.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Therefore, an assignable cause of "not confirmed" has been assigned to the reported event.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• 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: 8948187
• Report Number: 3008853977-2019-00062
• Device Sequence Number: 335372
• Product Code: KRA
• UDI-Device Identifier: 08714729301110
• UDI-Public: 08714729301110
• Combination Product (Y/N): N
• PMA/510(K) Number: K973645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2019

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: 11/12/2021
• Device Catalogue Number: M001182570
• Device Lot Number: 23077523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE(TERUMO).