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

Catalog Number	4002C2457
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was detached from the pusher assembly and the stretch resistant wire (sr wire) was fractured.Conclusions: evaluation of the returned device revealed the sr wire was fractured and the embolization coil was detached.Fracture of the sr wire typically occurs due to forceful retraction of the pc400 against resistance, and will allow the embolization coil to detach.This resistance may have occurred due to the embolization coil becoming pinned against patient anatomy or other devices used in the procedure.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.Penumbra coils 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal iliac artery (iia) using penumbra coil 400s (pc400s).During the procedure, the physician successfully deployed and detached four pc400s using a non-penumbra microcatheter.The distal tip of a fifth pc400 then began to take its shape while the pc400 was partially in the microcatheter and partially within the vessel outside of the aneurysm, and therefore the physician attempting to pull and push the pusher wire.Consequently, the pc400 unintentionally detached.The physician therefore placed the parent catheter into the target aneurysm and advanced the pc400 using the pusher wire, successfully placing the pc400 in the target location.The procedure was then completed using a new microcatheter, another pc400, and additional coils.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7232719
• Report Number: 3005168196-2018-00226
• Device Sequence Number: 1475734
• Product Code: HCG
• UDI-Device Identifier: 00814548010809
• UDI-Public: 00814548010809
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2018

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: 11/16/2024
• Device Catalogue Number: 4002C2457
• Device Lot Number: F72156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 01/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 84