MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER; NRY

Catalog Number 5MAXACE132

Device Problems Break (1069); Difficult to Insert (1316); Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2014

Event Type  malfunction  

Manufacturer Narrative

Result: the 5maxace catheter is fractured approximately 7.0, 17.0, and 20.0 cm from the hub.The break sites show material deformation and stretching.Conclusion: the device was returned for analysis and has been evaluated.The complaint indicates during the second attempt to introduce 5maxace catheter into the patient, the catheter kinked and broke in two locations.Evaluation of the returned catheter confirmed fractures in the catheter shaft in three locations in the proximal shaft of the device.These fractures showed evidence of material deformation and stretching of the material.The cause of these fractures is unknown.Damage such as this usually occurs when devices are advanced or retracted with force in excess of the tensile strength of the material.The device was functional prior to the second attempt to re-insert into the patient during the procedure.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a thrombectomy procedure using the penumbra system 5max ace reperfusion catheter.During the procedure, the physician introduced the 5max ace catheter for a second time after being partially successful in the first attempt.While inserting the 5 max ace catheter, it was kinked and subsequently broke at two positions.The physician used another 5max ace catheter to complete the procedure with no reported adverse effect on the patient.

• Brand Name: PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
• 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: 3691333
• MDR Text Key: 18766867
• Report Number: 3005168196-2014-00175
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K090752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F39530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2013
• 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: 63 YR