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

Catalog Number	4002C1660
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2018-00678.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the ophthalmic artery using penumbra coils 400 (pc400¿s) and a px slim delivery microcatheter (px slim).It was noted that the patient's anatomy was tortuous.During the procedure, while attempting to place the first pc400 into the aneurysm, the pc400 migrated down into the parent vessel; therefore, the physician decided to retract the pc400.While attempting to retract the pc400, it unintentionally detached with approximately four centimeters of the coil outside of the px slim.Therefore, the physician attached a syringe to the back of the px slim and applied suction to successfully remove the px slim and detached pc400 together.Upon removal of the px slim, it was noticed that the px slim was broken at the mid-shaft.The procedure was completed using the same sheath, a new px slim and additional pc400¿s.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pc400 pusher assembly was kinked approximately 20.0 and 112.0 cm from its proximal end (figure 4).The distal detachment tip (ddt) was sheared off and the embolization coil was detached.Conclusions: evaluation of the returned px slim revealed a fracture on the catheter¿s mid-shaft.This damage was likely a result of retracting the device against resistance.This is further supported by the material deformation near the fracture location.Further evaluation revealed a kink near the hub of the device.This damage was likely incidental and occurred post-procedure.Evaluation of the returned pc400 revealed the ddt sheared off of the pusher assembly and the embolization coil was detached within the returned px slim.This ddt likely sheared off as a result of being retracted against resistance.If the pc400 is retracted through a temporarily ovalized or necked catheter, ddt shearing may result.The resistance contributing to both the reported failures in this complaint may have been due to interactions between the devices being used and difficulty, tortuous anatomy.Penumbra catheters and 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: 7397470
• Report Number: 3005168196-2018-00679
• Device Sequence Number: 16160489
• Product Code: HCG
• UDI-Device Identifier: 00814548010724
• UDI-Public: 00814548010724
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2018

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
• Operator of Device: Physician
• Device Expiration Date: 04/08/2025
• Device Catalogue Number: 4002C1660
• Device Lot Number: F75542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1