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

Catalog Number	RBYPODJ15
Medical Device Problem Codes	Detachment Of Device Component (1104); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2017
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 numbers: 3005168196-2017-01918, 3005168196-2017-01919.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a splenic artery aneurysm using ruby coils, pod packing coils (podjs), and a lantern delivery microcatheter (lantern).It was reported that the patient had some tortuous anatomy, such as a 360 loop, however the rest of the vessel was navigated and supported by a diagnostic catheter.During the procedure, the physician successfully deployed and detached three ruby coils using the lantern.Afterwards, the physician was unable to advance another ruby coil out of the tip of the lantern, and upon retraction, the ruby coil unintentionally detached within the lantern.The physician, therefore, removed the lantern with the ruby coil inside and flushed out the ruby coil.The physician then successfully placed multiple ruby coils using the same lantern.However, while attempting to place a podj, the physician found that the podj was unable to advance and became stuck within the lantern.The podj then unintentionally detached and the physician removed the lantern with the podj inside.Outside of the patient, the physician was unable to flush the podj out of the lantern, and therefore, the physician completed the procedure using a new lantern and additional ruby coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The pod packing coil (podj) embolization coil was detached from the pusher assembly and the stretch resistant wire (sr wire) was fractured.Evaluation of the returned ruby coil revealed the embolization coil was detached, but had the proximal constraint sphere and sr wire intact.Since the sr wire was intact and the pusher assembly was not returned for evaluation, the root cause of the ruby coil unintentional detachment could not be determined.The pod packing coils (podj) embolization coil was detached and the sr wire was fractured.Fracture of the sr wire typically occurs due to forceful retraction of the podj against resistance, and will allow the embolization coil to detach from the pusher assembly.Further evaluation revealed the embolization coil had offset coil winds in multiple locations.This type of damage typically occurs due to forceful advancement of the podj against resistance.The lantern delivery microcatheter (lantern) had no visible damage, and a demonstration coil was advanced through the lantern without issue during functional analysis.Since the lantern functioned as intended and the pusher assemblies were not returned for evaluation, the root cause of the initial resistance experienced when advancing the ruby coil and podj could not be determined.Penumbra coils and catheters are 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.This report is associated with mfr report numbers: 3005168196-2017-01918; 3005168196-2017-01919.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6996689
• Report Number: 3005168196-2017-01920
• Device Sequence Number: 16607243
• Product Code: HCG
• UDI-Device Identifier: 00814548016702
• UDI-Public: 00814548016702
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/05/2017

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: 04/30/2025
• Device Catalogue Number: RBYPODJ15
• Device Lot Number: F76856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR