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

Catalog Number	4006C0306
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly.The stretch resistant wire (sr wire) was fractured and the embolization coil¿s proximal constraint sphere was inside the pusher assembly distal detachment tip (ddt).The embolization coil was detached from its pusher assembly and stuck inside its introducer sheath.Conclusion: evaluation of the returned pc400 revealed that the sr wire was fractured.This type of damage typically occurs due to forceful retraction against resistance.A pc400 must be retracted from its packaging hoop.The returned pc400 embolization coil was advanced out of the distal tip of its introducer sheath, which indicates that the pc400 was advanced after its removal from the hoop.The sr wire fracture may have occurred during attempts to re-sheath the embolization coil.This sr wire fracture would have caused the pc400 to detach within its introducer sheath.The second pc400 and the handle mentioned in the complaint was not returned for evaluation and, therefore, the root cause of the unable to detach issue could not be determined.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.This report is associated with mfr report numbers: 3005168196-2017-01855, 3005168196-2017-01856.
Event or Problem Description
The patient was undergoing a coil embolization in the right lumbar artery using penumbra coil 400's (pc400's) and a penumbra coil detachment handle (handle).During the procedure, the physician noticed that a pc400 had unintentionally detached within the packaging hoop when taking it out for the procedure.The damage to the pc400 occurred prior to use and therefore, it was not used in the procedure.The physician then advanced a new pc400 through the px slim delivery microcatheter (px slim), however the physician was unable to detach the pc400 using the handle, despite attempting to detach it multiple times.The physician therefore manually detached the pc400.The procedure was then completed using 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: 6978401
• Report Number: 3005168196-2017-01854
• Device Sequence Number: 900751
• Product Code: HCG
• UDI-Device Identifier: 00814548011837
• UDI-Public: 00814548011837
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2017

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: 09/24/2024
• Device Catalogue Number: 4006C0306
• Device Lot Number: F71756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR