MAUDE Adverse Event Report: PENUMBRA, INC. PX SLIM DELIVERY MICROCATHETER; DQY

Catalog Number PXSLIM045-B

Device Problems Activation, Positioning or Separation Problem (2906); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

Results: the px slim delivery microcatheter (px slim) was kinked under the strain relief approximately 2.0 cm from the hub.The strain relief was accidentally fractured by a penumbra investigator during analysis.The px slim was fractured approximately 89.0 cm from the hub.Conclusions: evaluation of the returned devices revealed the pc400 pusher assembly and px slim were fractured.This damage likely occurred during the physician's attempt to retrieve the pc400.The segment of the pc400 pusher assembly distal to the fracture was not returned for evaluation.Further evaluation revealed the pc400 was damaged throughout its length, and the px slim was kinked.This damage may have occurred due to forceful handling during advancement of the pc400 through the px slim, or during packaging for return.Since the distal segment of the pusher assembly was not returned and both devices were returned severely damaged, the root cause of the complaint could not be determined.Px slim devices are 100% visually evaluated during in-process inspection, and pc400 devices are 100% visually and functionally evaluated during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2016-00229.

Event Description

The patient was undergoing a coil embolization procedure using penumbra coil 400 coils (pc400 coils) and a px slim delivery microcatheter (px slim).During the procedure, while the physician was advancing the twenty-fourth pc400 coil through the px slim, the pc400 coil became stuck inside the px slim.While the coil was being retracted, it started to unravel inside the px slim.The physician removed both the pc400 coil and the px slim from the patient.The procedure was completed at this time since the angiography showed that the target vessel was occluded.There was no report of an adverse effect to the patient.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Type of Device: DQY
• 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: 5461810
• MDR Text Key: 39089187
• Report Number: 3005168196-2016-00230
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016412
• UDI-Public: 00814548016412
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2016

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: 08/31/2018
• Device Catalogue Number: PXSLIM045-B
• Device Lot Number: F65227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2015
• 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: 39 YR
• Patient Weight: 72