MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM REPERFUSION CATHETER 041; NRY

Catalog Number PSC041

Device Problems Kinked (1339); Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2014

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system reperfusion catheter 041.During the procedure while aspirating, the physician noticed that suction was not smooth; therefore, the reperfusion catheter 041 was removed.Upon removal, the reperfusion catheter revealed several kinks.The procedure continued with another manufacturer's device.There was no report of an adverse effect on the patient.

Manufacturer Narrative

The reperfusion catheter 041 was kinked 10.0 cm from the hub.The catheter was ovalized approximately 26.5, 30.0, 121.0 cm from the proximal end and 1.0 and 1.5 cm from the distal tip.The complaint has been evaluated.The compliant indicates that during use, suction through the reperfusion catheter 041 was not smooth.The catheter was subsequently removed and several kinks were observed.Evaluation of the returned product confirmed that the reperfusion catheter 041 was kinked along the shaft.The catheter was also ovalized along the shaft.This type of damage typically occurs when the device is improperly handled during preparation for use or insertion into the patient.These devices are 100% visually inspected for damage during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SYSTEM REPERFUSION CATHETER 041
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; 1351 harbor bay parkway; alameda, CA 94502 ; 5107483200
• MDR Report Key: 4112005
• MDR Text Key: 4697606
• Report Number: 3005168196-2014-00659
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K072718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2014

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
• Device Operator: Physician
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: PSC041
• Device Lot Number: F26715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2014
• Initial Date FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2012
• 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
• Patient Age: 74 YR