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

Catalog Number 5MAXACE132

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Kinked (1339)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the internal carotid artery using the penumbra system 5max ace 132 reperfusion catheter (5max ace 132).During preparation, after removing the 5max ace 132 from its packaging and flushing it with saline, the physician noticed that it was kinked and the proximal end of the catheter appeared to be dislodged from the catheter braid.The 5max ace 132 was removed and the procedure continued using a new 5max ace 132.There was no report of an adverse effect on the patient.

Manufacturer Narrative

Result: the penumbra system 5max ace reperfusion catheter (5max ace) was kinked approximately 3.0 cm from the hub.Conclusion: evaluation of the returned device confirmed it was kinked.This type of damage typically occurs due to improper handling during removal from the packaging.If the 5max ace is removed from the packaging hoop forcefully at an angle, damage such as this may occur.These devices are 100% visually inspected during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Manufacturer Narrative

Correction to sections: (b)(6) ,k133317.

• Brand Name: PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5104360
• MDR Text Key: 26771508
• Report Number: 3005168196-2015-00956
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012803
• UDI-Public: 00814548012803
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K133317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/27/2015

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: 01/31/2017
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F41040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2014
• 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: 69 YR