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

Catalog Number	RBYPODJ45
Medical Device Problem Codes	Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2018
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 treating an aneurysm in a renal fistula using pod packing coils (podjs).During the procedure, the physician successfully deployed and detached a ruby coil in the target location using a non-penumbra microcatheter.The physician then attempting to place a podj, however then retracted to reposition the podj because it was deploying in the parent vessel.While retracting the podj, it unintentionally detached while partially within the microcatheter.The physician attempted to remove the detached podj by retracting the microcatheter; however, it was unsuccessful.The physician then made a new groin puncture on the other side of the patient, inserted another microcatheter, and placed additional coils and ruby coils to block the detached podj from going into the flow.The physician then deployed and detached two other ruby coils.Next, the physician tried to move the detached podj into the target location by pushing it with its pusher assembly and another coil pusher assembly; however, it was unsuccessful.The physician then used a snare device and removed the detached podj from the patient.The procedure was completed using additional coils and stents.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the podj stretch resistant wire (sr wire) was fractured and the proximal constraint sphere was missing.The embolization coil was stuck inside the non-penumbra sheath and snare device.Conclusions: evaluation of the returned podj revealed that the sr wire was fractured.This damage was likely a result of forcefully retracting the device against resistance.The podj pusher assembly and non-penumbra microcatheter identified in the complaint were not returned for evaluation.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: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7451259
• Report Number: 3005168196-2018-00827
• Device Sequence Number: 10995711
• Product Code: HCG
• UDI-Device Identifier: 00814548016726
• UDI-Public: 00814548016726
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170852
• 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): 03/27/2018

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: 12/11/2025
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F80981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 06/25/2018
• 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