MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

Catalog Number 400SMTSFT0820

Device Problems Break (1069); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock on the proximal end of the penumbra smart coil (smart coil) pusher assembly was broken; the pusher was fractured approximately 184.0 cm from the proximal end; a segment of the pusher assembly approximately 3.5 cm long of the distal tip was fractured off and separated from the rest of the pusher assembly.The embolization coil to the smart coil was not returned for evaluation.Conclusions: evaluation of the returned device revealed that the pusher assembly was fractured.This type of damage typically occurs due to improper handling during use.If the rotating hemostasis valve (rhv) was not completely opened upon withdrawal of the device, the distal segment of the pusher assembly may become damaged.Smart coils are 100% functionally tested during in-process inspection.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 coil embolization procedure using penumbra smart coils (smart coils).During the procedure, the physician successfully delivered another manufacturer's coil and a smart coil into the patient.The physician then removed the smart coil's pusher assembly from the rotating hemostasis valve (rhv) with no issue and no noticeable friction.However, while inserting a new smart coil into the rhv, the physician observed that approximately 5 centimeters of the first smart coil's pusher assembly was stuck inside the transparent body of the rhv.The physician indicated that she may not have fully opened the rhv while retracting the pusher assembly of the first smart coil, which may have caused the pusher assembly to break inside the rhv.The physician removed the rhv and continued the procedure using a new rhv to deliver the second smart coil and a new smart coil into the patient.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the initial reporter's address that was reported on the initial mfr report was obtained via a web search engine because it was unknown at the time of the report.Since then, the manufacturer has obtained the correct address and it is being corrected on this report.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• 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: 5505808
• MDR Text Key: 40533225
• Report Number: 3005168196-2016-00316
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548014753
• UDI-Public: 00814548014753
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/15/2020
• Device Catalogue Number: 400SMTSFT0820
• Device Lot Number: F66987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2015
• 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: 45 YR