MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC CATH RAPIDTRANSIT 135CM W/EXT; CES MICROCATHETERS (KRA)

Catalog Number 601231

Device Problems Kinked (1339); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2015

Event Type  malfunction  

Manufacturer Narrative

The root cause cannot be determined as the product will not be returned.The lot number was not provided therefore a dhr review cannot be performed.Based on the information, the event could not be confirmed.The product was not returned for analysis and a device history record review cannot be completed because the lot for the product is unknown.Since the event could not be confirmed and there is no evidence of a manufacturing-related malfunction, no corrective actions will be taken at this time.Udi: lot # unknown.(b)(4).

Event Description

The contact at the hospital reported that the guidewire was stuck at the proximal end of the transit 2 microcatheter (601-231 / lot unknown).The procedure was the emergency peripheral percutaneous intervention of the lower extremity.The patient's details such as sex, dob, and the tortuosity and calcification level of the vessels were not available.Several cruise 14¿ guidewires (asahi intecc) were used for this procedure.The complaint transit was used to exchange the guidewire.However, it was reported that the guidewire was stuck at the proximal end of the microcatheter and could not be advanced.The transit was inspected and a kink was found at the proximal end.Another transit was used instead to continue the procedure.The procedure was completed without further issues.There were no patient injury/complications.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all times.No visible damage was noted on the product prior to the event.The complained product has already been disposed.No further information is available.

• Brand Name: CATH RAPIDTRANSIT 135CM W/EXT
• Type of Device: CES MICROCATHETERS (KRA)
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: kimberly soter ; 14700 nw 57th court; miami lakes, FL 33014 ; 5089777396
• MDR Report Key: 5176285
• MDR Text Key: 29204462
• Report Number: 1058196-2015-00192
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K972518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 601231
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1