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 Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2014

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system reperfusion catheter 041.During the procedure, the physician noted that the suction of the penumbra system reperfusion catheter 041 was not smooth.The penumbra system reperfusion catheter 041 was removed and was found to be kinked in several parts.The patient was cured with another penumbra catheter.There is no report of an adverse effect on the patient.

Manufacturer Narrative

Result: the catheter is ovalized approximately 1.0, 2.0, 17.0, 39.0, 72.0, and kinked 90.0 cm from the distal tip.Conclusion: the complaint has been evaluated.The complaint indicates that suction during the aspiration was not smooth.The catheter was removed and several kinks were found.Evaluation of the returned device confirmed several ovalizations and a kink along the length of the distal catheter shaft.This damage is commonly observed when the product is mishandled during preparation for use or during manipulation in the patient.These devices are 100% inspected for damage during processing.This damage was not noted upon inspection of the device out of the packaging before insertion into the patient.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: 3971911
• MDR Text Key: 4632901
• Report Number: 3005168196-2014-00501
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K090752
• 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: 07/04/2014

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: 03/31/2015
• Device Catalogue Number: PSC041
• Device Lot Number: F24943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2014
• Initial Date FDA Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2012
• 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: 61 YR