MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4004C0925
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400's (pc400's).During the procedure, while retracting a pc400 back into the lantern delivery microcatheter (lantern) in order to reposition the coil, the physician did not mention experiencing any resistance; however, the coil unintentionally detached.Most of the coil was inside the patient and a little tail of the coil remained in the lantern.Therefore, the physician accessed the contralateral and used a snare device to pull the pc400 out of the lantern and into the other manufacturer¿s catheter.While the pc400 was being pulled into the catheter, it broke in half.The physician was able to pull most of the coil through the catheter by hand and then removed the rest by pulling out the catheter.The procedure ended at this point.It should be noted that the physician did not use a rotating hemostasis valve (rhv) but did maintain a continuous flush during the procedure.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly.The pusher assembly was kinked approximately 22.5, 63.5 and 98.0 cm from the proximal end.The stretch resistant wire (sr wire) was fractured, and the pc400¿s embolization coil was unraveled and stuck inside the non-penumbra device.The proximal constraint sphere was not present during evaluation.Conclusions: evaluation of the returned device revealed that the pc400¿s embolization coil¿s sr wire was fractured.This type of damage typically occurs due to improper handling during use.Although the complaint indicated that the physician did not mention experiencing resistance upon retracting the pc400, sr wire fracture typically occurs if the device is forcefully retracted against resistance.The fractured sr wire likely caused the embolization coil to detach from the pusher assembly.Further evaluation revealed the embolization coil was unraveled.This damage likely occurred during retrieval of the detached embolization coil by a snare device.The kinks observed on the pusher assembly were likely incidental and may have occurred during packaging of the device for return to penumbra.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6111743
• Report Number: 3005168196-2016-01641
• Device Sequence Number: 19006526
• Product Code: HCG
• UDI-Device Identifier: 00814548010946
• UDI-Public: 00814548010946
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 4004C0925
• Device Lot Number: F43894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2016
• Supplement Report FDA Received Date: 01/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR